Interventions for treating cavitated or dentine carious lesions.

BACKGROUND: Traditionally, cavitated carious lesions and those extending into dentine have been treated by 'complete' removal of carious tissue, i.e. non-selective removal and conventional restoration (CR). Alternative strategies for managing cavitated or dentine carious lesions remove less or none of the carious tissue and include selective carious tissue removal (or selective excavation (SE)), stepwise carious tissue removal (SW), sealing carious lesions using sealant materials, sealing using preformed metal crowns (Hall Technique, HT), and non-restorative cavity control (NRCC). OBJECTIVES: To determine the comparative effectiveness of interventions (CR, SE, SW, sealing of carious lesions using sealant materials or preformed metal crowns (HT), or NRCC) to treat carious lesions conventionally considered to require restorations (cavitated or micro-cavitated lesions, or occlusal lesions that are clinically non-cavitated but clinically/radiographically extend into dentine) in primary or permanent teeth with vital (sensitive) pulps. SEARCH METHODS: An information specialist searched four bibliographic databases to 21 July 2020 and used additional search methods to identify published, unpublished and ongoing studies.  SELECTION CRITERIA: We included randomised clinical trials comparing different levels of carious tissue removal, as listed above, against each other, placebo, or no treatment. Participants had permanent or primary teeth (or both), and vital pulps (i.e. no irreversible pulpitis/pulp necrosis), and carious lesions conventionally considered to need a restoration (i.e. cavitated lesions, or non- or micro-cavitated lesions radiographically extending into dentine). The primary outcome was failure, a composite measure of pulp exposure, endodontic therapy, tooth extraction, and restorative complications (including resealing of sealed lesions). DATA COLLECTION AND ANALYSIS: Pairs of review authors independently screened search results, extracted data, and assessed the risk of bias in the studies and the overall certainty of the evidence using GRADE criteria. We measured treatment effects through analysing dichotomous outcomes (presence/absence of complications) and expressing them as odds ratios (OR) with 95% confidence intervals (CI). For failure in the subgroup of deep lesions, we used network meta-analysis to assess and rank the relative effectiveness of different interventions. MAIN RESULTS: We included 27 studies with 3350 participants and 4195 teeth/lesions, which were conducted in 11 countries and published between 1977 and 2020. Twenty-four studies used a parallel-group design and three were split-mouth. Two studies included adults only, 20 included children/adolescents only and five included both. Ten studies evaluated permanent teeth, 16 evaluated primary teeth and one evaluated both. Three studies treated non-cavitated lesions; 12 treated cavitated, deep lesions, and 12 treated cavitated but not deep lesions or lesions of varying depth.  Seventeen studies compared conventional treatment (CR) with a less invasive treatment: SE (8), SW (4), two HT (2), sealing with sealant materials (4) and NRCC (1). Other comparisons were: SE versus HT (2); SE versus SW (4); SE versus sealing  with sealant materials (2); sealant materials versus no sealing (2).  Follow-up times varied from no follow-up (pulp exposure during treatment) to 120 months, the most common being 12 to 24 months. All studies were at overall high risk of bias. Effect of interventions Sealing using sealants versus other interventions for non-cavitated or cavitated but not deep lesions There was insufficient evidence of a difference between sealing with sealants and CR (OR 5.00, 95% CI 0.51 to 49.27; 1 study, 41 teeth, permanent teeth, cavitated), sealing versus SE (OR 3.11, 95% CI 0.11 to 85.52; 2 studies, 82 primary teeth, cavitated) or sealing versus no treatment (OR 0.05, 95% CI 0.00 to 2.71; 2 studies, 103 permanent teeth, non-cavitated), but we assessed all as very low-certainty evidence. HT, CR, SE, NRCC for cavitated, but not deep lesions in primary teeth The odds of failure may be higher for CR than HT (OR 8.35, 95% CI 3.73 to 18.68; 2 studies, 249 teeth; low-certainty evidence) and lower for HT than NRCC (OR 0.19, 95% CI 0.05 to 0.74; 1 study, 84 teeth, very low-certainty evidence). There was insufficient evidence of a difference between SE versus HT (OR 8.94, 95% CI 0.57 to 139.67; 2 studies, 586 teeth) or CR versus NRCC (OR 1.16, 95% CI 0.50 to 2.71; 1 study, 102 teeth), both very low-certainty evidence. CR, SE, SW for deep lesions The odds of failure were higher for CR than SW in permanent teeth (OR 2.06, 95% CI 1.34 to 3.17; 3 studies, 398 teeth; moderate-certainty evidence), but not primary teeth (OR 2.43, 95% CI 0.65 to 9.12; 1 study, 63 teeth; very low-certainty evidence). The odds of failure may be higher for CR than SE in permanent teeth (OR 11.32, 95% CI 1.97 to 65.02; 2 studies, 179 teeth) and primary teeth (OR 4.43, 95% CI 1.04 to 18.77; 4 studies, 265 teeth), both very low-certainty evidence. Notably, two studies compared CR versus SE in cavitated, but not deep lesions, with insufficient evidence of a difference in outcome (OR 0.62, 95% CI 0.21 to 1.88; 204 teeth; very low-certainty evidence). The odds of failure were higher for SW than SE in permanent teeth (OR 2.25, 95% CI 1.33 to 3.82; 3 studies, 371 teeth; moderate-certainty evidence), but not primary teeth (OR 2.05, 95% CI 0.49 to 8.62; 2 studies, 126 teeth; very low-certainty evidence). For deep lesions, a network meta-analysis showed the probability of failure to be greatest for CR compared with SE, SW and HT. AUTHORS' CONCLUSIONS: Compared with CR, there were lower numbers of failures with HT and SE in the primary dentition, and with SE and SW in the permanent dentition. Most studies showed high risk of bias and limited precision of estimates due to small sample size and typically limited numbers of failures, resulting in assessments of low or very low certainty of evidence for most comparisons.

Outcomes used in trials regarding the prevention and treatment of orthodontically induced white spot lesions: A scoping review.

INTRODUCTION: The objective was to identify and summarize the outcomes and evaluation methods used in clinical trials regarding the prevention and treatment of orthodontically induced white spot lesions (WSLs). METHODS: Three electronic databases were searched to identify studies that were (1) clinical trials on prevention and/or treatment of orthodontically induced WSLs, (2) reported in English, and (3) published between January 2010 and October 2019. At least 2 authors assessed the eligibility and extracted the characteristics, outcomes, and evaluation methods from included studies. All disagreements were resolved through discussion. RESULTS: Among 1328 studies identified, 51 were eligible and included. A total of 48 different outcomes and 11 different evaluation methods were used in these studies. The most frequently used outcomes were WSLs clinical visual examination scores (n = 22, 43.1%), DIAGNOdent values (n = 14; 27.5%), fluorescence loss measured with quantitative light-induced fluorescence (QLF) (n = 10; 19.6%), and lesion area measured with QLF (n = 10; 19.6%). The most frequently used evaluation methods were clinical examination (n = 25; 49.0%), visual inspection by photographs (n = 15; 29.4%), DIAGNOdent (n = 14; 27.5%), and QLF (n = 10; 19.6%). None of the included studies reported data on quality of life. CONCLUSIONS: Substantial outcome heterogeneity exists among studies regarding the prevention and treatment of orthodontically induced WSLs. Most of the identified outcomes are aimed to assess morphologic changes of WSLs and may not reflect patient perspectives. REGISTRATION: The Core Outcome Set for trials on the prevention and treatment of enamel White Spot Lesions (COS-WSL) project was registered in the COMET Initiative database (No. 1399).

Occlusal schemes for complete dentures.

Data sourcesMedline, Scopus and Cochrane Library databases supplemented by searches in the journals; American Journal of Dentistry, Clinical Oral Investigation, International Journal of Prosthodontics, Journal of Dental Research, Journal of Oral Rehabilitation, Journal of Prosthodontics, Journal of Prosthodontic Research, Journal of Advanced Prosthodontics and Journal of Prosthetic Dentistry.Study selectionRandomised controlled trials (RCTs) or prospective studies comparing bilateral balanced occlusion (BBO) with other schemes, eg lingual occlusion (LO) canine guidance (CG) and neutral-centric or zero-degree (ZD).Data extraction and synthesisOne reviewer extracted the data and two reviewers assessed risk of bias using the Newcastle-Ottawa scale for non-randomised studies and the Cochrane risk of bias tool for RCTs. A narrative summary of the findings was presented.ResultsSeventeen studies, 11 RCTs and six prospective studies involving a total of 492 were included. Average follow-up period was 2.96 months (range 1-6 months). Six RCTs were considered to be at low risk of bias, two at unclear risk and three at high risk. Studies compared BBO with LO, CG and ZD. Twelve out of 16 studies reported on quality of life and patients satisfaction.ConclusionsThe present systematic review indicated that BBO does not confer better quality of life/satisfaction or masticatory performance and muscle activity. Thus, lingualised occlusion can be considered a predictable occlusal scheme for complete dentures in terms of quality of life/satisfaction and masticatory performance, while canine guidance can be used to reduce muscular activity.

HEMA-free or HEMA-containing adhesive systems for non-carious cervical lesions.

Data sourcesMedline/PubMed, Web of Science, Open Grey, Scopus and Cochrane Library databases were searched with no restrictions on dates or language.Study selectionRandomised controlled clinical trials (RCTs) comparing the effectiveness of HEMA-free and HEMA-containing adhesive systems in NCCL restorations were included.Data extraction and synthesisTwo reviewers extracted data with risk of bias being assessed using the Cochrane tool. The parameters, retention [RE], marginal adaptation [MA], marginal discoloration [MD], caries [CA], postoperative sensitivity [POS] and overall clinical performance were assessed using a random effects meta-analysis.ResultsTwenty-two studies were included, 13 were at low risk of bias and nine at unclear risk. The number of patients in the studies ranged from 11-124 and study duration ranged from 12 months to 13 years. In all 30 different adhesive systems were tested. For the parameters analysed no significant statistical differences were found between the clinical performances of HEMA-free and HEMA-containing adhesive systems.ConclusionsHEMA-free and HEMA-containing adhesive systems showed a similar clinical performance in NCCL restorations.

Shortened dental arch concept shown to be cost effective.

DESIGN: Randomised controlled trial. INTERVENTION: All patients received treatment to render them dentally fit. Patients were randomly allocated to either the removable dental prostheses (RPD) or the shortened dental arch (SDA) group. Patients in the RDP group were restored to complete arches with RDP using cobalt-chromium frameworks according to a standardised protocol. For the SDA group, patients were restored to a shortened arch of ten occluding pairs of natural and replacement teeth using resin-bonded bridgework (RBB). OUTCOME MEASURE: Treatment effect was measured using the change in oral health-related quality of life (OHrQOL). For each patient the costs of delivering treatment were recorded by a research nurse during the intervention period. Laboratory costs were recorded as part of normal hospital policy for all patients. All of the dental materials used were recorded and given a unit price. The cost of professional time per patient was estimated using the highest point of the salary scale for the Community Dental Service in Ireland. RESULTS: One hundred and thirty-two patients were randomised; 65 to the RPD group and 67 to the SDA group. Ninety-two patients (69.7%) completed the study (46 in RPD group; 46in SDA group). There was no difference in the success rates of the two treatments over the period. Five pieces of resin-bonded bridgework (RBB) debonded and were recemented over the 12-month period giving a success rate of 95.5% for the RBB. Four patients discontinued wearing their RPDs; all four RPDS were fitted in the lower arch and included bilateral free end saddles, a success rate of 95.9%. Both RPD and SDA groups demonstrated statistically significant improvements in OHrQoL scores after 12 months.The total cost of achieving the minimally important clinical difference (MID) in OHrQOL for an average patient in the RDP group was [euro ]464.64. For the SDA group, the cost of achieving the MID for an average patient was [euro ]252.00. The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment. CONCLUSIONS: With an increasingly ageing population, many patients will continue to benefit from removable prostheses to replace their missing natural teeth. From a purely economic standpoint, the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective.

Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL).

BACKGROUND: Enamel white spot lesions (WSLs), characterized by an opaque, matt, and chalky white appearance of enamel, are a sign of incipient caries. WSLs are common in orthodontic practice and can affect both the oral health and dental aesthetics of patients. Extensive studies have been conducted to evaluate the effectiveness of prevention or treatment for orthodontically induced enamel WSLs. However, substantial heterogeneity has been found in the outcomes used for the prevention and treatment of WSLs in literature, which prevents researchers from comparing and combining the results of different studies to draw more decisive conclusions. Therefore, we aim to develop a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL). METHODS: The development of COS-OWSL comprises four phases: (1) a scoping review to identify and summarize all existing outcomes that have been used in trials on the prevention or treatment of orthodontically induced WSLs; (2) qualitative interviews with orthodontic patients without (for prevention) and with WSL-affected teeth (for treatment) and relevant dental professionals to identify additional outcomes relevant to them; (3) Delphi surveys to collect opinions from key stakeholders including patients, dental professionals, and researchers and to reach a preliminary consensus; and (4) a consensus meeting to develop the final COS-OWSL. DISCUSSION: The COS-OWSL will be developed to facilitate the synthesis of evidence regarding the prevention and treatment of orthodontically induced WSLs and to promote the consistent use of relevant patient-important outcomes among future studies in this field. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) initiative (the COS-WSL project) 1399.

Reporting quality of systematic review abstracts in operative dentistry: An assessment using the PRISMA for Abstracts guidelines.

OBJECTIVES: To assess and compare the reporting quality of systematic review (SR) abstracts in operative dentistry published before and after the release of Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Abstracts (PRISMA-A), and to identify factors associated with reporting quality. METHODS: PubMed was searched for abstracts published during 2010-2012 (Pre-PRISMA period) and 2017-2019 (Post-PRISMA period). Reporting quality was assessed and scored using a modified 13-item PRSIMA-A checklist. Risk ratio (RR) was used to compare the adequate reporting rate of each item between the two periods. Univariable and multivariable linear regression analyses were performed to identify factors associated with reporting quality. RESULTS: A total of 160 abstracts were included and assessed. Only four items ('objective', 'results of main outcomes', 'description of the effect' and 'interpretation') were adequately reported in most abstracts (>75 %). According to the multivariable analysis, greater word count (P = 0.001), being published in the Post-PRISMA period (P = 0.025) and geographic origin from Asia (P = 0.025) or South America (P = 0.015) were significantly associated with higher reporting quality. CONCLUSIONS/CLINICAL SIGNIFICANCE: The reporting quality of SR abstracts in operative dentistry had improved significantly after the publication of PRISMA-A, but was still suboptimal. Researchers, reviewers and journal editors in operative dentistry need to be familiar with the PRISMA-A checklist, and make concerted efforts to improve the reporting of SR abstracts.

The Problem: Relevance, Quality, and Homogeneity of Trial Designs, Outcomes, and Reporting.

Clinical trials are the cornerstone of evidence-based medicine. By directly comparing different interventions they produce evidence on their relative efficacy and effectiveness This, in turn, can inform secondary research and guideline development to facilitate evidence-based clinical decision making. However, the quality of evidence stemming from clinical trials is frequently poor. Here, the pathway of evidence from basic research to the generation of implementable clinical guidelines will be described. Relevant factors related to trial design and reporting, such as the choice of trial comparators, outcomes and outcome measures, will be described and their influence on evidence synthesis will be discussed. Finally, recommendations on how to improve trials in order to increase their usefulness for evidence generation will be given.

Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review.

BACKGROUND: Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations. METHODS: PubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). INCLUSION CRITERIA: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly. RESULTS: Of 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968-1980 and 2001-2010, reporting of outcome 'caries experience' reduced from 39% to 18%; 'clinical performance of the restoration' reporting increased from 33% to 42% although there was a reduction to 22% in 2011-2015. Emerging outcome domains include 'lesion activity' and 'pulp health-related outcomes', accounting for 1% and 0%, respectively, during 1968-1980 and 10% and 4% for 2011-2015. Reporting 'resource efficiency' and 'quality of life measures' have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports. CONCLUSIONS: Over the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future. TRIAL REGISTRATION: PROSPERO, CRD42015025310 . Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017).

Comparator choice in cariology trials limits conclusions on the comparative effectiveness of caries interventions.

OBJECTIVES: Comparator choice has been found as one major factor impacting on the overall evidence supporting clinical interventions. We performed social network analysis (SNA) on trials on the prevention/management of caries/carious lesions, hypothesizing that certain comparators are proportionally overinvestigated, and others underinvestigated, and that comparisons within comparator classes are preferred over comparisons between classes. STUDY DESIGN AND SETTING: A systematic review of randomized controlled trials on the prevention/management of caries/existing carious lesions was carried out. All comparators were classified at each of three levels of granularity, becoming more detailed with each level: (1) degree of invasiveness (noninvasive, microinvasive, or invasive), (2) the specific noninvasive, microinvasive, or invasive approach, and (3) the actual material or technique used. SNA was used to evaluate trial networks. RESULTS: Searching electronic databases found 4,774 articles; of which, 764 were relevant and 605 were included. The networks for all levels were polygonal. There was a high degree of separation of comparisons in prevention vs. management trials. Invasive comparators were tested most frequently (number of comparators: 592), mainly in management trials. Noninvasive comparators were tested next often (464), mainly in caries prevention. Microinvasive strategies were tested next often (234), in both prevention and management trials. On more granular levels, few interventions dominated the networks. Regardless of the level, most trials compared within and not between classes. Prevention trials were mainly conducted in children (number of trials in adults/children/both: 37/240/11), whereas those on managing lesions were conducted in both children and adults (117/176/21). CONCLUSION: Comparator choice in cariology trials is driven by indication and limits conclusions on the true comparative effectiveness of all strategies. There are a variety of comparators that have not been, but should be, compared with one another, which should be addressed by future trials. Factors underlying trialists' comparator choice need to be identified.