Developing a core outcome set for periodontal trials.

BACKGROUND: There is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals. OBJECTIVE: Develop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases. METHODS: Mixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting. PARTICIPANTS: Key stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers. RESULTS: The literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss. CONCLUSIONS: Implementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions. REGISTRATION: COMET Database: http://www.comet-initiative.org/studies/details/265?result=true.

What is the most accurate method for detecting caries lesions? A systematic review.

OBJECTIVE: To perform a systematic review and meta-analysis of the performance of different methods for detecting carious lesions in permanent and primary teeth, considering all types of tooth surface. METHODS: Two reviewers searched PubMed, Embase, Scopus and other sources up to November 2020 to identify published and nonpublished studies in English. We focused on three caries detection methods: visual inspection (VI), radiographic (RX) and fluorescence-based (LF). We included studies investigating at least one of these methods which (a) assessed the accuracy of the method in detecting caries lesions; (b) considered occlusal, proximal or free smooth surfaces in primary or permanent teeth; (c) used a reference standard other than one of the three methods; and (d) reported data on sample size and accuracy. Multilevel analyses, meta-regressions and comparisons of bivariate summary receiver operating characteristics curves were undertaken. RESULTS: Two hundred and forty manuscripts from 14 129 articles initially identified met the inclusion criteria. VI was better than RX on occlusal surfaces at all caries lesion thresholds and proximal surfaces of permanent teeth only at all lesion thresholds in laboratory setting. LF was slightly better than VI for advanced lesions on occlusal surfaces of permanent teeth in the clinical setting and for all lesions on proximal surfaces of permanent teeth in the laboratory setting. Still, LF was worse than VI for advanced occlusal lesions in permanent teeth in the laboratory setting. Although LF showed slightly better performance than VI with advanced lesions, the latter had significantly higher specificity than other methods in all settings. CONCLUSION: Visual caries detection alone is adequate for most patients in daily clinical practice regardless of tooth type or surface.

INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial: a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care.

BACKGROUND: Traditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group's systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care. METHODS: This is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life. DISCUSSION: INTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice. TRIAL REGISTRATION: ISRCTN95933794 (Date assigned 20/08/2008).

Core outcomes in periodontal trials: study protocol for core outcome set development.

BACKGROUND: There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets are an agreed, standardised list of outcomes that should be measured and reported in all trials in specific clinical areas. We aim to develop a core outcome set for effectiveness trials investigating the prevention and management of periodontal disease in primary or secondary care. METHODS: To identify existing outcomes we screened the Cochrane systematic reviews and their included studies on the prevention and management of periodontal diseases. The core outcome set will be defined by consensus of key stakeholders using an online e-Delphi process and face-to-face meeting. Key stakeholders involved in the development will include: patients, dentists, hygienists/therapists, specialists, clinical researchers and policy-makers. Stakeholders will be asked to prioritise outcomes and feedback will be provided in the next round(s). Stakeholders will have an opportunity to add outcomes found in the Cochrane review screening process at the end of the first round. If consensus is not reached after the second round we will provide feedback prior to a third round. Remaining outcomes will be discussed at a face-to-face meeting and agreement will be measured via defined consensus rules of outcome inclusion. DISCUSSION: The inclusive consensus process should provide a core outcome set that is relevant to all key stakeholders. We will actively disseminate our findings to help improve clinical trials, systematic reviews and clinical guidelines with the ultimate aim of improving the prevention and management of periodontal diseases. TRIAL REGISTRATION: COMET ( http://www.comet-initiative.org/studies/details/265?result=true ). Registered on August 2012.

Provisional Restorations ­ A Permanent Problem?

Provisional restorations play an important role when providing indirect restorations. There are a number of materials and techniques available for their construction. Careful planning and construction can protect the prepared tooth surface, improve the periodontal condition and help plan for the definitive restoration. A good provisional restoration can save time, money and effort. Clinical relevance: Provisional restoration construction is an integral part of the indirect restorative process for inlays, onlays, crowns and bridges.

The non-operative resin treatment of proximal caries lesions.

UNLABELLED: Epidemiological data show that the prevalence of caries on proximal surfaces in need of operative treatment is very high around the world, both in the primary and the permanent dentition. This article presents two new treatment methods: proximal sealing and proximal infiltration. The indications are progressing proximal caries lesions, radiographically with a depth around the enamel-dentine junction. A small number of studies regarding the effect of sealing and infiltration on proximal caries versus the use of fluoride varnish, placebo treatment and flossing instructions have been carried out. About half of the studies disclose a not significant difference between test and control treatment. In the other half, the therapeutic effect is significant and corresponds to about 30% reduction in lesion progression. However, longitudinal studies of longer duration are lacking. CLINICAL RELEVANCE: Proximal sealing and proximal infiltration may have a place in the treatment of non-cavitated proximal lesions. Proximal caries is a problem in both primary and permanent dentitions. Proximal sealants or lesion infiltration are possible treatments.

Performance of laser fluorescence at tooth surface and histological section.

This study aimed to evaluate a laser fluorescence device (the DIAGNOdent) and a visual classification system (ICDAS-II) for occlusal caries diagnosis. It also aimed to determine whether fluorescence measurements taken at the tooth surface correlate with the fluorescence measurements taken within the body of the lesion. The occlusal surfaces of 100 extracted permanent teeth were examined using ICDAS-II and DIAGNOdent (LF-tooth). Serial sections were made and lesion depth was assessed histologically. DIAGNOdent readings were also taken from the sections (LF-section). There were significant positive strong correlations between ICDAS-II and histology (r(S) = 0.71) and LF-section and histology (r(S) = 0.70), and only moderate correlations between LF-tooth and histology (r(S) = 0.51) and LF-tooth and LF-section (r(S) = 0.60). Diagnostic accuracy for ICDAS-II was generally better than for LF-tooth. While the DIAGNOdent device provides an objective reading for detection and monitoring of carious lesions, using the cut-off ranges previously suggested leads to inferior performance.

Parameters associated with active caries lesions assessed by two different visual scoring systems on occlusal surfaces of primary molars - a multilevel approach.

UNLABELLED: OBJECTIVE: The aim of this in vivo study was to evaluate the association between several parameters related to children and to their teeth, and the presence of active carious lesions assessed by two different visual indices on occlusal surfaces of primary molars. METHODS: Occlusal surfaces of 757 primary molars in 139 children (3-12 years old) were classified as sound, or having inactive or active carious lesions using the Nyvad criteria (NY) and the International Caries Detection and Assessment System (ICDAS-II) and a supplemental lesion activity assessment system (ICDAS-LAA). Several parameters related to the tooth and to the child were recorded. Associations between these parameters and the presence of active carious lesions on occlusal surfaces were evaluated using logistic multilevel analysis. RESULTS: Second primary molar teeth and children with high caries experience were more frequently with active occlusal carious lesions compared to sound and inactive occlusal carious lesions classified by both visual scoring systems. Teeth with a mature dental plaque on the occlusal surface and younger children had more active caries than inactive occlusal carious lesions (excluding sound teeth in the analysis). A previous visit to a dentist was related to a lower frequency of active occlusal carious lesions classified by NY only, and upper primary molars presented with higher numbers of active occlusal carious lesions classified by ICDAS-LAA. CONCLUSIONS: Presence of mature dental plaque and tooth type are tooth-related variables associated with active carious lesions on occlusal surfaces of primary teeth, as well as anterior caries experience and age are variables related to the child.

Occlusal caries: Evaluation of direct microscopy versus digital imaging used for two histological classification systems.

OBJECTIVE: Histology is frequently used as a gold standard to validate caries detection devices. Poor assessment consistency could lead to apparent changes in diagnostic accuracy. In multi-center, multi-examiner studies electronic transfer of information would be convenient, provided there is no deteriation in quality. This study tested the hypothesis that examiner reproducibility in the assessment of caries lesion depth when viewing photographic images of histological sections on a computer monitor, is comparable with viewing the same sections under a microscope using two histological classification systems. METHODS: 166 investigation sites (96 teeth) were selected for visual examination (ICDAS-II) and sections made using a novel technique which reduced risk of section damage and allowed accurate allocation of section to each investigation site. Digital images of the sections were produced and four examiners viewed the sections under a microscope and on a separate occasion corresponding digital images on a computer monitor. Presence and extent of caries was scored according to two histological classification systems (Downer, ERK). RESULTS: The inter- and intra-examiner reproducibility for both histological classification systems and both examination techniques was substantial to almost perfect (weighted kappa=0.63-0.90). Comparing the kappa values between microscopy and viewing digital images, there was no effect or only a small effect between both examination techniques (effect size 0.00-0.28). There was also a strong relationship between the two viewing techniques (r(s)=0.748-0.844). CONCLUSIONS: Viewing digital images of tooth sections produces results comparable to viewing images directly under a microscope and therefore has potential benefits for multi-centre studies.

Impact of Scoring Single or Multiple Occlusal Lesions on Estimates of Diagnostic Accuracy of the Visual ICDAS-II System.

Carious lesions can occur at different sites on the occlusal surfaces of teeth and may differ in appearance and severity. This study aimed to evaluate how estimates of reproducibility and accuracy of ICDAS-II were affected when all lesions on occlusal surfaces, or only a representative lesion, were scored. 100 permanent teeth with 1-4 investigation sites on the occlusal surface were examined visually by four examiners. Serial sections of the teeth were assessed for lesion depth. Intra- and interexaminer reproducibility (weighted kappa values), sensitivity, and specificity were calculated for all investigation sites and for a randomly selected site per tooth. Comparing the kappa values for the whole sample and the independent sites, no effect or only a small effect was found. Comparing the areas under the ROC-curves no effect could be shown. Examining multiple sites on teeth leads to results comparable to when a single independent site is chosen per tooth.

Management of the compromised tooth.

Modern endodontic and restorative techniques allow some teeth previously thought to be unsaveable to be aesthetically restored to function. This paper discusses the use of such techniques and is illustrated with a case report.