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The Cochrane Database of Systematic... Jul 2018Pain during dental treatment, which is a common fear of patients, can be controlled successfully by local anaesthetic. Several different local anaesthetic formulations... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pain during dental treatment, which is a common fear of patients, can be controlled successfully by local anaesthetic. Several different local anaesthetic formulations and techniques are available to dentists.
OBJECTIVES
Our primary objectives were to compare the success of anaesthesia, the speed of onset and duration of anaesthesia, and systemic and local adverse effects amongst different local anaesthetic formulations for dental anaesthesia. We define success of anaesthesia as absence of pain during a dental procedure, or a negative response to electric pulp testing or other simulated scenario tests. We define dental anaesthesia as anaesthesia given at the time of any dental intervention.Our secondary objective was to report on patients' experience of the procedures carried out.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2018, Issue 1), MEDLINE (OVID SP), Embase, CINAHL PLUS, WEB OF SCIENCE, and other resources up to 31 January 2018. Other resources included trial registries, handsearched journals, conference proceedings, bibliographies/reference lists, and unpublished research.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) testing different formulations of local anaesthetic used for clinical procedures or simulated scenarios. Studies could apply a parallel or cross-over design.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological approaches for data collection and analysis.
MAIN RESULTS
We included 123 studies (19,223 participants) in the review. We pooled data from 68 studies (6615 participants) for meta-analysis, yielding 23 comparisons of local anaesthetic and 57 outcomes with 14 different formulations. Only 10 outcomes from eight comparisons involved clinical testing.We assessed the included studies as having low risk of bias in most domains. Seventy-three studies had at least one domain with unclear risk of bias. Fifteen studies had at least one domain with high risk of bias due to inadequate sequence generation, allocation concealment, masking of local anaesthetic cartridges for administrators or outcome assessors, or participant dropout or exclusion.We reported results for the eight most important comparisons.Success of anaesthesiaWhen the success of anaesthesia in posterior teeth with irreversible pulpitis requiring root canal treatment is tested, 4% articaine, 1:100,000 epinephrine, may be superior to 2% lidocaine, 1:100,000 epinephrine (31% with 2% lidocaine vs 49% with 4% articaine; risk ratio (RR) 1.60, 95% confidence interval (CI) 1.10 to 2.32; 4 parallel studies; 203 participants; low-quality evidence).When the success of anaesthesia for teeth/dental tissues requiring surgical procedures and surgical procedures/periodontal treatment, respectively, was tested, 3% prilocaine, 0.03 IU felypressin (66% with 3% prilocaine vs 76% with 2% lidocaine; RR 0.86, 95% CI 0.79 to 0.95; 2 parallel studies; 907 participants; moderate-quality evidence), and 4% prilocaine plain (71% with 4% prilocaine vs 83% with 2% lidocaine; RR 0.86, 95% CI 0.75 to 0.99; 2 parallel studies; 228 participants; low-quality evidence) were inferior to 2% lidocaine, 1:100,000 epinephrine.Comparative effects of 4% articaine, 1:100,000 epinephrine and 4% articaine, 1:200,000 epinephrine on success of anaesthesia for teeth/dental tissues requiring surgical procedures are uncertain (RR 0.85, 95% CI 0.71 to 1.02; 3 parallel studies; 930 participants; very low-quality evidence).Comparative effects of 0.5% bupivacaine, 1:200,000 epinephrine and both 4% articaine, 1:200,000 epinephrine (odds ratio (OR) 0.87, 95% CI 0.27 to 2.83; 2 cross-over studies; 37 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (OR 0.58, 95% CI 0.07 to 5.12; 2 cross-over studies; 31 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction are uncertain.Comparative effects of 2% mepivacaine, 1:100,000 epinephrine and both 4% articaine, 1:100,000 epinephrine (OR 3.82, 95% CI 0.61 to 23.82; 1 parallel and 1 cross-over study; 110 participants; low-quality evidence) and 2% lidocaine, 1:100,000 epinephrine (RR 1.16, 95% CI 0.25 to 5.45; 2 parallel studies; 68 participants; low-quality evidence) on success of anaesthesia for teeth requiring extraction and teeth with irreversible pulpitis requiring endodontic access and instrumentation, respectively, are uncertain.For remaining outcomes, assessing success of dental local anaesthesia via meta-analyses was not possible.Onset and duration of anaesthesiaFor comparisons assessing onset and duration, no clinical studies met our outcome definitions.Adverse effects (continuous pain measured on 170-mm Heft-Parker visual analogue scale (VAS))Differences in post-injection pain between 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine are small, as measured on a VAS (mean difference (MD) 4.74 mm, 95% CI -1.98 to 11.46 mm; 3 cross-over studies; 314 interventions; moderate-quality evidence). Lidocaine probably resulted in slightly less post-injection pain than articaine (MD 6.41 mm, 95% CI 1.01 to 11.80 mm; 3 cross-over studies; 309 interventions; moderate-quality evidence) on the same VAS.For remaining comparisons assessing local and systemic adverse effects, meta-analyses were not possible. Other adverse effects were rare and minor.Patients' experiencePatients' experience of procedures was not assessed owing to lack of data.
AUTHORS' CONCLUSIONS
For success (absence of pain), low-quality evidence suggests that 4% articaine, 1:100,000 epinephrine was superior to 2% lidocaine, 1:100,000 epinephrine for root treating of posterior teeth with irreversible pulpitis, and 2% lidocaine, 1:100,000 epinephrine was superior to 4% prilocaine plain when surgical procedures/periodontal treatment was provided. Moderate-quality evidence shows that 2% lidocaine, 1:100,000 epinephrine was superior to 3% prilocaine, 0.03 IU felypressin when surgical procedures were performed.Adverse events were rare. Moderate-quality evidence shows no difference in pain on injection when 4% articaine, 1:100,000 epinephrine and 2% lidocaine, 1:100,000 epinephrine were compared, although lidocaine resulted in slightly less pain following injection.Many outcomes tested our primary objectives in simulated scenarios, although clinical alternatives may not be possible.Further studies are needed to increase the strength of the evidence. These studies should be clearly reported, have low risk of bias with adequate sample size, and provide data in a format that will allow meta-analysis. Once assessed, results of the 34 'Studies awaiting classification (full text unavailable)' may alter the conclusions of the review.
Topics: Anesthesia, Dental; Anesthetics, Local; Dental Care; Humans; Pain Measurement; Randomized Controlled Trials as Topic
PubMed: 29990391
DOI: 10.1002/14651858.CD006487.pub2 -
The Cochrane Database of Systematic... Mar 2023Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals via... (Review)
Review
BACKGROUND
Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals via implanted electrodes into the spinal cord. The long term benefits and harms of SCS for people with low back pain are uncertain.
OBJECTIVES
To assess the effects, including benefits and harms, of SCS for people with low back pain.
SEARCH METHODS
On 10 June 2022, we searched CENTRAL, MEDLINE, Embase, and one other database for published trials. We also searched three clinical trials registers for ongoing trials.
SELECTION CRITERIA
We included all randomised controlled trials and cross-over trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was SCS versus placebo, at the longest time point measured in the trials. Major outcomes were mean low back pain intensity, function, health-related quality of life, global assessment of efficacy, withdrawals due to adverse events, adverse events, and serious adverse events. Our primary time point was long-term follow-up (≥ 12 months).
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 13 studies with 699 participants: 55% of participants were female; mean age ranged from 47 to 59 years; and all participants had chronic low back pain with mean duration of symptoms ranging from five to 12 years. Ten cross-over trials compared SCS with placebo. Three parallel-group trials assessed the addition of SCS to medical management. Most studies were at risk of performance and detection bias from inadequate blinding and selective reporting bias. The placebo-controlled trials had other important biases, including lack of accounting for period and carryover effects. Two of the three parallel trials assessing SCS as an addition to medical management were at risk of attrition bias, and all three had substantial cross-over to the SCS group for time points beyond six months. In the parallel-group trials, we considered the lack of placebo control to be an important source of bias. None of our included studies evaluated the impact of SCS on mean low back pain intensity in the long term (≥ 12 months). The studies most often assessed outcomes in the immediate term (less than one month). At six months, the only available evidence was from a single cross-over trial (50 participants). There was moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo. Pain was 61 points (on a 0- to 100-point scale, 0 = no pain) at six months with placebo, and 4 points better (8.2 points better to 0.2 points worse) with SCS. Function was 35.4 points (on a 0- to 100-point scale, 0 = no disability or best function) at six months with placebo, and 1.3 points better (3.9 points better to 1.3 points worse) with SCS. Health-related quality of life was 0.44 points out of 1 (0 to 1 index, 0 = worst quality of life) at six months with placebo, and 0.04 points better (0.16 points better to 0.08 points worse) with SCS. In that same study, nine participants (18%) experienced adverse events and four (8%) required revision surgery. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeated surgery. We could not provide effect estimates of the relative risks as events were not reported for the placebo period. In parallel trials assessing SCS as an addition to medical management, it is uncertain whether, in the medium or long term, SCS can reduce low back pain, leg pain, or health-related quality of life, or if it increases the number of people reporting a 50% improvement or better, because the certainty of the evidence was very low. Low-certainty evidence suggests that adding SCS to medical management may slightly improve function and slightly reduce opioid use. In the medium term, mean function (0- to 100-point scale; lower is better) was 16.2 points better with the addition of SCS to medical management compared with medical management alone (95% confidence interval (CI) 19.4 points better to 13.0 points better; I = 95%; 3 studies, 430 participants; low-certainty evidence). The number of participants reporting opioid medicine use was 15% lower with the addition of SCS to medical management (95% CI 27% lower to 0% lower; I = 0%; 2 studies, 290 participants; low-certainty evidence). Adverse events with SCS were poorly reported but included infection and lead migration. One study found that, at 24 months, 13 of 42 people (31%) receiving SCS required revision surgery. It is uncertain to what extent the addition of SCS to medical management increases the risk of withdrawals due to adverse events, adverse events, or serious adverse events, because the certainty of the evidence was very low.
AUTHORS' CONCLUSIONS
Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention.
Topics: Female; Humans; Male; Middle Aged; Analgesics, Opioid; Low Back Pain; Quality of Life; Spinal Cord Stimulation
PubMed: 36878313
DOI: 10.1002/14651858.CD014789.pub2 -
The Cochrane Database of Systematic... Jul 2020Pathology relating to mandibular wisdom teeth is a frequent presentation to oral and maxillofacial surgeons, and surgical removal of mandibular wisdom teeth is a common... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pathology relating to mandibular wisdom teeth is a frequent presentation to oral and maxillofacial surgeons, and surgical removal of mandibular wisdom teeth is a common operation. The indications for surgical removal of these teeth are alleviation of local pain, swelling and trismus, and also the prevention of spread of infection that may occasionally threaten life. Surgery is commonly associated with short-term postoperative pain, swelling and trismus. Less frequently, infection, dry socket (alveolar osteitis) and trigeminal nerve injuries may occur. This review focuses on the optimal methods in order to improve patient experience and minimise postoperative morbidity.
OBJECTIVES
To compare the relative benefits and risks of different techniques for surgical removal of mandibular wisdom teeth.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health Trials Register (to 8 July 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2019, Issue 6), MEDLINE Ovid (1946 to 8 July 2019), and Embase Ovid (1980 to 8 July 2019). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication.
SELECTION CRITERIA
Randomised controlled trials comparing different surgical techniques for the removal of mandibular wisdom teeth.
DATA COLLECTION AND ANALYSIS
Three review authors were involved in assessing the relevance of identified studies, evaluated the risk of bias in included studies and extracted data. We used risk ratios (RRs) for dichotomous data in parallel-group trials (or Peto odds ratios if the event rate was low), odds ratios (ORs) for dichotomous data in cross-over or split-mouth studies, and mean differences (MDs) for continuous data. We took into account the pairing of the split-mouth studies in our analyses, and combined parallel-group and split-mouth studies using the generic inverse-variance method. We used the fixed-effect model for three studies or fewer, and random-effects model for more than three studies.
MAIN RESULTS
We included 62 trials with 4643 participants. Several of the trials excluded individuals who were not in excellent health. We assessed 33 of the studies (53%) as being at high risk of bias and 29 as unclear. We report results for our primary outcomes below. Comparisons of different suturing techniques and of drain versus no drain did not report any of our primary outcomes. No studies provided useable data for any of our primary outcomes in relation to coronectomy. There is insufficient evidence to determine whether envelope or triangular flap designs led to more alveolar osteitis (OR 0.33, 95% confidence interval (CI) 0.09 to 1.23; 5 studies; low-certainty evidence), wound infection (OR 0.29, 95% CI 0.04 to 2.06; 2 studies; low-certainty evidence), or permanent altered tongue sensation (Peto OR 4.48, 95% CI 0.07 to 286.49; 1 study; very low-certainty evidence). In terms of other adverse effects, two studies reported wound dehiscence at up to 30 days after surgery, but found no difference in risk between interventions. There is insufficient evidence to determine whether the use of a lingual retractor affected the risk of permanent altered sensation compared to not using one (Peto OR 0.14, 95% CI 0.00 to 6.82; 1 study; very low-certainty evidence). None of our other primary outcomes were reported by studies included in this comparison. There is insufficient evidence to determine whether lingual split with chisel is better than a surgical hand-piece for bone removal in terms of wound infection (OR 1.00, 95% CI 0.31 to 3.21; 1 study; very low-certainty evidence). Alveolar osteitis, permanent altered sensation, and other adverse effects were not reported. There is insufficient evidence to determine whether there is any difference in alveolar osteitis according to irrigation method (mechanical versus manual: RR 0.33, 95% CI 0.01 to 8.09; 1 study) or irrigation volume (high versus low; RR 0.52, 95% CI 0.27 to 1.02; 1 study), or whether there is any difference in postoperative infection according to irrigation method (mechanical versus manual: RR 0.50, 95% CI 0.05 to 5.43; 1 study) or irrigation volume (low versus high; RR 0.17, 95% CI 0.02 to 1.37; 1 study) (all very low-certainty evidence). These studies did not report permanent altered sensation and adverse effects. There is insufficient evidence to determine whether primary or secondary wound closure led to more alveolar osteitis (RR 0.99, 95% CI 0.41 to 2.40; 3 studies; low-certainty evidence), wound infection (RR 4.77, 95% CI 0.24 to 96.34; 1 study; very low-certainty evidence), or adverse effects (bleeding) (RR 0.41, 95% CI 0.11 to 1.47; 1 study; very low-certainty evidence). These studies did not report permanent sensation changes. Placing platelet rich plasma (PRP) or platelet rich fibrin (PRF) in sockets may reduce the incidence of alveolar osteitis (OR 0.39, 95% CI 0.22 to 0.67; 2 studies), but the evidence is of low certainty. Our other primary outcomes were not reported.
AUTHORS' CONCLUSIONS
In this 2020 update, we added 27 new studies to the original 35 in the 2014 review. Unfortunately, even with the addition of these studies, we have been unable to draw many meaningful conclusions. The small number of trials evaluating each comparison and reporting our primary outcomes, along with methodological biases in the included trials, means that the body of evidence for each of the nine comparisons evaluated is of low or very low certainty. Participant populations in the trials may not be representative of the general population, or even the population undergoing third molar surgery. Many trials excluded individuals who were not in good health, and several excluded those with active infection or who had deep impactions of their third molars. Consequently, we are unable to make firm recommendations to surgeons to inform their techniques for removal of mandibular third molars. The evidence is uncertain, though we note that there is some limited evidence that placing PRP or PRF in sockets may reduce the incidence of dry socket. The evidence provided in this review may be used as a guide for surgeons when selecting and refining their surgical techniques. Ongoing studies may allow us to provide more definitive conclusions in the future.
Topics: Adult; Bias; Drainage; Dry Socket; Humans; Lip; Mandible; Middle Aged; Molar, Third; Postoperative Complications; Randomized Controlled Trials as Topic; Sensation Disorders; Surgical Flaps; Surgical Wound Infection; Therapeutic Irrigation; Tongue; Tooth Extraction; Tooth, Impacted; Wound Closure Techniques; Young Adult
PubMed: 32712962
DOI: 10.1002/14651858.CD004345.pub3 -
Anaesthesia Feb 2018Loop diuretics remain a fundamental pharmacological therapy to remove excess fluid and improve symptom control in acute decompensated heart failure. Several recent... (Comparative Study)
Comparative Study Meta-Analysis
Continuous infusion vs. intermittent bolus injection of furosemide in acute decompensated heart failure: systematic review and meta-analysis of randomised controlled trials.
Loop diuretics remain a fundamental pharmacological therapy to remove excess fluid and improve symptom control in acute decompensated heart failure. Several recent randomised controlled trials have examined the clinical benefit of continuous vs. bolus furosemide in acute decompensated heart failure, but have reported conflicting findings. The aim of this review was to compare the effects of continuous and bolus furosemide with regard to mortality, length of hospital stay and its efficacy profile in acute decompensated heart failure. All parallel-arm randomised controlled trials from MEDLINE, EMBASE, PubMed and the Cochrane Database of Systematic Reviews from inception until May 2017 were included. Cross-over randomised controlled trials, observational studies, case reports, case series and non-systematic reviews that involved children were excluded. Eight trials (n = 669) were eligible for inclusion. There was no difference between furosemide continuous infusion and bolus administration for all-cause mortality (four studies; n = 491; I = 0%; OR 1.65; 95%CI 0.93-2.91; p = 0.08) or duration of hospitalisation (six studies; n = 576; I = 71%; mean difference 0.27; 95%CI -1.35 to 1.89 days; p = 0.74). Continuous infusion of intravenous furosemide was associated with increased weight reduction (five studies; n = 516; I = 0%; mean difference 0.70; 95%CI 0.12-1.28 kg; p = 0.02); increased total urine output in 24 h (four studies; n = 390; I = 33%; mean difference 461.5; 95%CI 133.7-789.4 ml; p < 0.01); and reduced brain natriuretic peptide (two studies; n = 390; I = 0%; mean difference 399.5; 95%CI 152.7-646.3 ng.l ; p < 0.01), compared with the bolus group. There was no difference in the incidence of raised creatinine and hypokalaemia between the two groups. In summary, there was no difference between continuous infusion and bolus of furosemide for all-cause mortality, length of hospital stay and electrolyte disturbance, but continuous infusion was superior to bolus administration with regard to diuretic effect and reduction in brain natriuretic peptide.
Topics: Acute Disease; Diuretics; Furosemide; Heart Failure; Humans; Infusions, Intravenous; Injections, Intravenous; Length of Stay
PubMed: 28940440
DOI: 10.1111/anae.14038 -
The Cochrane Database of Systematic... Oct 2007Sleep bruxism is an oral activity characterised by teeth grinding or clenching during sleep. Several treatments for sleep bruxism have been proposed such as... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sleep bruxism is an oral activity characterised by teeth grinding or clenching during sleep. Several treatments for sleep bruxism have been proposed such as pharmacological, psychological, and dental.
OBJECTIVES
To evaluate the effectiveness of occlusal splints for the treatment of sleep bruxism with alternative interventions, placebo or no treatment.
SEARCH STRATEGY
We searched the Cochrane Oral Health Group's Trials Register (to May 2007); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 1); MEDLINE (1966 to May 2007); EMBASE (1980 to May 2007); LILACS (1982 to May 2007); Biblioteca Brasileira de Odontologia (1982 to May 2007); Dissertation, Theses and Abstracts (1981 to May 2007); and handsearched abstracts of particular importance to this review. Additional reports were identified from the reference lists of retrieved reports and from article reviews about treating sleep bruxism. There were no language restrictions.
SELECTION CRITERIA
We selected randomised or quasi-randomised controlled trials (RCTs), in which splint therapy was compared concurrently to no treatment, other occlusal appliances, or any other intervention in participants with sleep bruxism.
DATA COLLECTION AND ANALYSIS
Data extraction was carried out independently and in duplicate. Validity assessment of the included trials was carried out at the same time as data extraction. Discrepancies were discussed and a third review author consulted. The author of the primary study was contacted when necessary.
MAIN RESULTS
Thirty-two potentially relevant RCTs were identified. Twenty-four trials were excluded. Five RCTs were included. Occlusal splint was compared to: palatal splint, mandibular advancement device, transcutaneous electric nerve stimulation, and no treatment. There was just one common outcome (arousal index) which was combined in a meta-analysis. No statistically significant differences between the occlusal splint and control groups were found in the meta-analyses.
AUTHORS' CONCLUSIONS
There is not sufficient evidence to state that the occlusal splint is effective for treating sleep bruxism. Indication of its use is questionable with regard to sleep outcomes, but it may be that there is some benefit with regard to tooth wear. This systematic review suggests the need for further investigation in more controlled RCTs that pay attention to method of allocation, outcome assessment, large sample size, and sufficient duration of follow up. The study design must be parallel, in order to eliminate the bias provided by studies of cross-over type. A standardisation of the outcomes of the treatment of sleep bruxism should be established in the RCTs.
Topics: Humans; Occlusal Splints; Randomized Controlled Trials as Topic; Sleep Bruxism
PubMed: 17943862
DOI: 10.1002/14651858.CD005514.pub2 -
The Cochrane Database of Systematic... Dec 2017Dental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dental caries is a sugar-dependent disease that damages tooth structure and, due to loss of mineral components, may eventually lead to cavitation. Dental caries is the most prevalent disease worldwide and is considered the most important burden of oral health. Conventional treatment methods (drill and fill) involve the use of rotary burs under local anaesthesia. The need for an electricity supply, expensive handpieces and highly trained dental health personnel may limit access to dental treatment, especially in underdeveloped regions.To overcome the limitations of conventional restorative treatment, the Atraumatic Restorative Treatment (ART) was developed, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. ART is a minimally invasive approach which involves removal of decayed tissue using hand instruments alone, usually without use of anaesthesia and electrically driven equipment, and restoration of the dental cavity with an adhesive material (glass ionomer cement (GIC), composite resins, resin-modified glass-ionomer cement (RM-GICs) and compomers).
OBJECTIVES
To assess the effects of Atraumatic Restorative Treatment (ART) compared with conventional treatment for managing dental caries lesions in the primary and permanent teeth of children and adults.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 1), MEDLINE Ovid (1946 to 22 February 2017), Embase Ovid (1980 to 22 February 2017), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 22 February 2017) and BBO BIREME Virtual Health Library (Bibliografia Brasileira de Odontologia; 1986 to 22 February 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least six months' follow-up that compared the effects of ART with a conventional restorative approach using the same or different restorative dental materials to treat caries lesions.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results, extracted data from included studies and assessed the risk of bias in those studies. We used standard methodological procedures expected by Cochrane to evaluate risk of bias and synthesise data. Where pooling was appropriate we conducted meta-analyses using the random-effects model. We assessed the quality of the evidence using GRADE criteria.
MAIN RESULTS
We included a total of 15 eligible studies randomising 3760 participants in this review. The age of participants across the studies ranged from 3 to 101 years, with a mean of 25.42 years. 48% of participants were male. All included studies were published between 2002 and 2016. Two of the 15 studies declared that the financial support was from companies that manufacture restorative material. Five studies were individually randomised parallel-group studies; six were cluster-randomised parallel-group studies; and four were randomised studies that used a split-mouth design. Eleven studies evaluated the effects of ART on primary teeth only, and four on permanent teeth. The follow-up period of the included studies ranged from 6 months to 36 months. We judged all studies to be at high risk of bias.For the main comparison of ART compared to conventional treatment using the same material: all but two studies used high-viscosity glass ionomer (H-GIC) as the restorative material; one study used a composite material; and one study used resin-modified glass ionomer cement (RM-GIC)).Compared to conventional treatment using H-GIC, ART may increase the risk of restoration failure in the primary dentition, over a follow-up period from 12 to 24 months (OR 1.60, 95% CI 1.13 to 2.27, five studies; 643 participants analysed; low-quality evidence). Our confidence in this effect estimate is limited due to serious concerns over risk of performance and attrition bias. For this comparison, ART may reduce pain during procedure compared with conventional treatment (MD -0.65, 95% CI -1.38 to 0.07; 40 participants analysed; low-quality evidence)Comparisons of ART to conventional treatment using composite or RM-GIC were downgraded to very low quality due to indirectness, imprecision and high risk of performance and attrition bias. Given the very low quality of the evidence from single studies, we are uncertain about the restoration failure of ART compared with conventional treatment using composite over a 24-month follow-up period (OR 1.11, 95% CI 0.54 to 2.29; one study; 57 participants) and ART using RM-GIC in the permanent teeth of older adults with root caries lesions over a six-month follow-up period (OR 2.71, 95% CI 0.94 to 7.81; one study; 64 participants).No studies reported on adverse events or costs.
AUTHORS' CONCLUSIONS
Low-quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth. The effects of ART using composite and RM-GIC are uncertain due to the very low quality of the evidence and we cannot rely on the findings. Most studies evaluated the effects of ART on the primary dentition.Well-designed RCTs are required that report on restoration failure at clinically meaningful time points, as well as participant-reported outcomes such as pain and discomfort. Due to the potential confounding effects from the use of different dental materials, a robust body of evidence on the effects of ART compared with conventional treatment using the same restoration material is necessary. We identified four ongoing trials that could provide further insights into this area.
Topics: Adult; Child; Dental Atraumatic Restorative Treatment; Dental Caries; Dental Restoration Failure; Dentition, Permanent; Female; Glass Ionomer Cements; Humans; Male; Randomized Controlled Trials as Topic; Tooth, Deciduous; Toothache
PubMed: 29284075
DOI: 10.1002/14651858.CD008072.pub2 -
BMC Psychiatry Feb 2018There is increasing recognition of the therapeutic function pets can play in relation to mental health. However, there has been no systematic review of the evidence... (Review)
Review
BACKGROUND
There is increasing recognition of the therapeutic function pets can play in relation to mental health. However, there has been no systematic review of the evidence related to the comprehensive role of companion animals and how pets might contribute to the work associated with managing a long-term mental health condition. The aim of this study was to explore the extent, nature and quality of the evidence implicating the role and utility of pet ownership for people living with a mental health condition.
METHODS
A systematic search for studies exploring the role of companion animals in the management of mental health conditions was undertaken by searching 9 databases and undertaking a scoping review of grey literature from the earliest record until March 2017. To be eligible for inclusion, studies had to be published in English and report on primary data related to the relationship between domestic animal ownership and the management of diagnosable mental health conditions. Synthesis of qualitative and quantitative data was undertaken in parallel using a narrative synthesis informed by an illness work theoretical framework.
RESULTS
A total of 17 studies were included in the review. Quantitative evidence relating to the benefits of pet ownership was mixed with included studies demonstrating positive, negative and neutral impacts of pet ownership. Qualitative studies illuminated the intensiveness of connectivity people with companion animals reported, and the multi-faceted ways in which pets contributed to the work associated with managing a mental health condition, particularly in times of crisis. The negative aspects of pet ownership were also highlighted, including the practical and emotional burden of pet ownership and the psychological impact that losing a pet has.
CONCLUSION
This review suggests that pets provide benefits to those with mental health conditions. Further research is required to test the nature and extent of this relationship, incorporating outcomes that cover the range of roles and types of support pets confer in relation to mental health and the means by which these can be incorporated into the mainstay of support for people experiencing a mental health problem.
Topics: Animals; Emotions; Human-Animal Bond; Humans; Mental Disorders; Mental Health; Narration; Pets; Qualitative Research
PubMed: 29402247
DOI: 10.1186/s12888-018-1613-2 -
BMC Psychiatry Nov 2019Over the past decade, smartphone use has become widespread amongst today's children and young people (CYP) which parallels increases in poor mental health in this group.... (Meta-Analysis)
Meta-Analysis
Prevalence of problematic smartphone usage and associated mental health outcomes amongst children and young people: a systematic review, meta-analysis and GRADE of the evidence.
BACKGROUND
Over the past decade, smartphone use has become widespread amongst today's children and young people (CYP) which parallels increases in poor mental health in this group. Simultaneously, media concern abounds about the existence of 'smartphone addiction' or problematic smartphone use. There has been much recent research concerning the prevalence of problematic smartphone use is in children and young people who use smartphones, and how this syndrome relates to mental health outcomes, but this has not been synthesized and critically evaluated.
AIMS
To conduct a systematic review and meta-analysis to examine the prevalence of PSU and quantify the association with mental health harms.
METHODS
A search strategy using Medical Subject Headings was developed and adapted for eight databases between January 1, 1st 2011 to October 15th 2017. No language restriction was applied. Of 924 studies identified, 41 were included in this review, three of which were cohort studies and 38 were cross sectional studies. The mental health outcomes were self-reported: depression; anxiety; stress; poor sleep quality; and decreased educational attainment, which were synthesized according to an a priori protocol.
RESULTS
The studies included 41,871 CYP, and 55% were female. The median prevalence of PSU amongst CYP was 23.3% (14.0-31.2%). PSU was associated with an increased odds of depression (OR = 3.17;95%CI 2.30-4.37;I = 78%); increased anxiety (OR = 3.05 95%CI 2.64-3.53;I = 0%); higher perceived stress (OR = 1.86;95%CI 1.24-2.77;I = 65%); and poorer sleep quality (OR = 2.60; 95%CI; 1.39-4.85, I = 78%).
CONCLUSIONS
PSU was reported in approximately one in every four CYP and accompanied by an increased odds of poorer mental health. PSU is an evolving public health concern that requires greater study to determine the boundary between helpful and harmful technology use. Policy guidance is needed to outline harm reduction strategies.
Topics: Adolescent; Anxiety; Behavior, Addictive; Child; Depression; Educational Status; Female; Humans; Male; Mental Health; Odds Ratio; Prevalence; Self Report; Sleep Wake Disorders; Smartphone; Stress, Psychological; Young Adult
PubMed: 31779637
DOI: 10.1186/s12888-019-2350-x -
The Cochrane Database of Systematic... Jun 2022Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been... (Review)
Review
BACKGROUND
Acute respiratory distress syndrome (ARDS) is a significant cause of hospitalisation and death in young children. Positioning and mechanical ventilation have been regularly used to reduce respiratory distress and improve oxygenation in hospitalised patients. Due to the association of prone positioning (lying on the abdomen) with sudden infant death syndrome (SIDS) within the first six months, it is recommended that young infants be placed on their back (supine). However, prone positioning may be a non-invasive way of increasing oxygenation in individuals with acute respiratory distress, and offers a more significant survival advantage in those who are mechanically ventilated. There are substantial differences in respiratory mechanics between adults and infants. While the respiratory tract undergoes significant development within the first two years of life, differences in airway physiology between adults and children become less prominent by six to eight years old. However, there is a reduced risk of SIDS during artificial ventilation in hospitalised infants. Thus, an updated review focusing on positioning for infants and young children with ARDS is warranted. This is an update of a review published in 2005, 2009, and 2012.
OBJECTIVES
To compare the effects of different body positions in hospitalised infants and children with acute respiratory distress syndrome aged between four weeks and 16 years.
SEARCH METHODS
We searched CENTRAL, which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE, Embase, and CINAHL from January 2004 to July 2021.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or quasi-RCTs comparing two or more positions for the management of infants and children hospitalised with ARDS.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from each study. We resolved differences by consensus, or referred to a third contributor to arbitrate. We analysed bivariate outcomes using an odds ratio (OR) and 95% confidence interval (CI). We analysed continuous outcomes using a mean difference (MD) and 95% CI. We used a fixed-effect model, unless heterogeneity was significant (I statistic > 50%), when we used a random-effects model.
MAIN RESULTS
We included six trials: four cross-over trials, and two parallel randomised trials, with 198 participants aged between 4 weeks and 16 years, all but 15 of whom were mechanically ventilated. Four trials compared prone to supine positions. One trial compared the prone position to good-lung dependent (where the person lies on the side of the healthy lung, e.g. if the right lung was healthy, they were made to lie on the right side), and independent (or non-good-lung independent, where the person lies on the opposite side to the healthy lung, e.g. if the right lung was healthy, they were made to lie on the left side) position. One trial compared good-lung independent to good-lung dependent positions. When the prone (with ventilators) and supine positions were compared, there was no information on episodes of apnoea or mortality due to respiratory events. There was no conclusive result in oxygen saturation (SaO MD 0.40 mmHg, 95% CI -1.22 to 2.66; 1 trial, 30 participants; very low certainty evidence); blood gases, PCO (MD 3.0 mmHg, 95% CI -1.93 to 7.93; 1 trial, 99 participants; low certainty evidence), or PO (MD 2 mmHg, 95% CI -5.29 to 9.29; 1 trial, 99 participants; low certainty evidence); or lung function (PaO/FiO ratio; MD 28.16 mmHg, 95% CI -9.92 to 66.24; 2 trials, 121 participants; very low certainty evidence). However, there was an improvement in oxygenation index (FiO% X M/ PaO) with prone positioning in both the parallel trials (MD -2.42, 95% CI -3.60 to -1.25; 2 trials, 121 participants; very low certainty evidence), and the cross-over study (MD -8.13, 95% CI -15.01 to -1.25; 1 study, 20 participants). Derived indices of respiratory mechanics, such as tidal volume, respiratory rate, and positive end-expiratory pressure (PEEP) were reported. There was an apparent decrease in tidal volume between prone and supine groups in a parallel study (MD -0.60, 95% CI -1.05 to -0.15; 1 study, 84 participants; very low certainty evidence). When prone and supine positions were compared in a cross-over study, there were no conclusive results in respiratory compliance (MD 0.07, 95% CI -0.10 to 0.24; 1 study, 10 participants); changes in PEEP (MD -0.70 cm HO, 95% CI -2.72 to 1.32; 1 study, 10 participants); or resistance (MD -0.00, 95% CI -0.05 to 0.04; 1 study, 10 participants). One study reported adverse events. There were no conclusive results for potential harm between groups in extubation (OR 0.57, 95% CI 0.13 to 2.54; 1 trial, 102 participants; very low certainty evidence); obstructions of the endotracheal tube (OR 5.20, 95% CI 0.24 to 111.09; 1 trial, 102 participants; very low certainty evidence); pressure ulcers (OR 1.00, 95% CI 0.41 to 2.44; 1 trial, 102 participants; very low certainty evidence); and hypercapnia (high levels of arterial carbon dioxide; OR 3.06, 95% CI 0.12 to 76.88; 1 trial, 102 participants; very low certainty evidence). One study (50 participants) compared supine positions to good-lung dependent and independent positions. There was no conclusive evidence that PaO was different between supine and good-lung dependent positioning (MD 3.44 mm Hg, 95% CI -23.12 to 30.00; 1 trial, 25 participants; very low certainty evidence). There was also no conclusive evidence for supine position and good-lung independent positioning (MD -2.78 mmHg, 95% CI -28.84, 23.28; 25 participants; very low certainty evidence); or between good-lung dependent and independent positioning (MD 6.22, 95% CI -21.25 to 33.69; 1 trial, 25 participants; very low certainty evidence). As most trials did not describe how possible biases were addressed, the potential for bias in these findings is unclear.
AUTHORS' CONCLUSIONS
Although included studies suggest that prone positioning may offer some advantage, there was little evidence to make definitive recommendations. There appears to be low certainty evidence that positioning improves oxygenation in mechanically ventilated children with ARDS. Due to the increased risk of SIDS with prone positioning and lung injury with artificial ventilation, it is recommended that hospitalised infants and children should only be placed in this position while under continuous cardiorespiratory monitoring.
Topics: Adult; Child; Child, Preschool; Humans; Infant; Infant, Newborn; Patient Positioning; Positive-Pressure Respiration; Respiration, Artificial; Respiratory Distress Syndrome; Sudden Infant Death
PubMed: 35661343
DOI: 10.1002/14651858.CD003645.pub4 -
The Cochrane Database of Systematic... Jun 2018This is an update of the original Cochrane Review published in Issue 4, 2011.Attention deficit hyperactivity disorder (ADHD) is the most prevalent of the comorbid... (Review)
Review
BACKGROUND
This is an update of the original Cochrane Review published in Issue 4, 2011.Attention deficit hyperactivity disorder (ADHD) is the most prevalent of the comorbid psychiatric disorders that complicate tic disorders. Medications commonly used to treat ADHD symptoms include stimulants such as methylphenidate and amphetamine; non-stimulants, such as atomoxetine; tricyclic antidepressants; and alpha agonists. Alpha agonists are also used as a treatment for tics. Due to the impact of ADHD symptoms on the child with tic disorder, treatment of ADHD is often of greater priority than the medical management of tics. However, for many decades, clinicians have been reluctant to use stimulants to treat children with ADHD and tics for fear of worsening their tics. OBJECTIVES: To assess the effects of pharmacological treatments for ADHD in children with comorbid tic disorders on symptoms of ADHD and tics.
SEARCH METHODS
In September 2017, we searched CENTRAL, MEDLINE, Embase, and 12 other databases. We also searched two trial registers and contacted experts in the field for any ongoing or unpublished studies.
SELECTION CRITERIA
We included randomized, double-blind, controlled trials of any pharmacological treatment for ADHD used specifically in children with comorbid tic disorders. We included both parallel-group and cross-over study designs.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures of Cochrane, in that two review authors independently selected studies, extracted data using standardized forms, assessed risk of bias, and graded the overall quality of the evidence by using the GRADE approach.
MAIN RESULTS
We included eight randomized controlled trials (four of which were cross-over trials) with 510 participants (443 boys, 67 girls) in this review. Participants in these studies were children with both ADHD and a chronic tic disorder. All studies took place in the USA and ranged from three to 22 weeks in duration. Five of the eight studies were funded by charitable organizations or government agencies, or both. One study was funded by the drug manufacturer. The other two studies did not specify the source of funding. Risk of bias of included studies was low for blinding; low or unclear for random sequence generation, allocation concealment, and attrition bias; and low or high for selective outcome reporting. We were unable to combine any of the studies in a meta-analysis due to important clinical heterogeneity and unit-of-analysis issues.Several of the trials assessed multiple agents. Medications assessed included methylphenidate, clonidine, desipramine, dextroamphetamine, guanfacine, atomoxetine, and deprenyl. There was low-quality evidence for methylphenidate, atomoxetine, and clonidine, and very low-quality evidence for desipramine, dextroamphetamine, guanfacine and deprenyl in the treatment of ADHD in children with tics. All studies, with the exception of a study using deprenyl, reported improvement in symptoms of ADHD. Tic symptoms also improved in children treated with guanfacine, desipramine, methylphenidate, clonidine, and a combination of methylphenidate and clonidine. In one study, tics limited further dosage increases of methylphenidate. High-dose dextroamphetamine appeared to worsen tics in one study, although the length of this study was limited to three weeks. There was appetite suppression or weight loss in association with methylphenidate, dextroamphetamine, atomoxetine, and desipramine. There was insomnia associated with methylphenidate and dextroamphetamine, and sedation associated with clonidine.
AUTHORS' CONCLUSIONS
Following an updated search of potentially relevant studies, we found no new studies that matched our inclusion criteria and thus our conclusions have not changed.Methylphenidate, clonidine, guanfacine, desipramine, and atomoxetine appear to reduce ADHD symptoms in children with tics though the quality of the available evidence was low to very low. Although stimulants have not been shown to worsen tics in most people with tic disorders, they may, nonetheless, exacerbate tics in individual cases. In these instances, treatment with alpha agonists or atomoxetine may be an alternative. Although there is evidence that desipramine may improve tics and ADHD in children, safety concerns will likely continue to limit its use in this population.
Topics: Adolescent; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Child, Preschool; Clonidine; Desipramine; Dextroamphetamine; Female; Guanfacine; Humans; Male; Methylphenidate; Randomized Controlled Trials as Topic; Selegiline; Tic Disorders
PubMed: 29944175
DOI: 10.1002/14651858.CD007990.pub3