Thomas Lamont

Why we need a core outcome set for trials of interventions for prevention and management of caries.

Why we need a core outcome set for trials of interventions for prevention and management of caries

Practical considerations for conducting dental clinical trials in primary care

There is increasing importance placed on conducting clinical trials in dentistry to provide a robust evidence base for the treatment provided, and models of care delivered. However, providing the evidence upon which to base such decisions is not straightforward, as the conduct of these trials is complex. Currently, only limited information is available about the strategies to deliver successful clinical trials in primary care settings, and even less available on dental clinical trials. Considerable knowledge and experience is lost once a trial is completed as details about effective management of a trial are generally not reported or disseminated to trial managers and researchers. This leads to loss of vital knowledge that could assist with the effective delivery of new trials. The aim of this study is to examine the conduct and delivery of five dental clinical trials across both Australia and the UK and identify the various factors that impacted upon their implementation. Findings suggest that early stakeholder engagement, and well-designed and managed trials, lead to improved outcomes for researchers, clinic staff and patients, and increases the potential for future dissemination and translation of information into practice.

Radiotherapy associated with higher rates of dental implant loss

Data sourcesCochrane Oral Health Groups Trials Register, CENTRAL, Medline via PubMed and EMBASE; no restrictions on language, published before February 1st 2013.Study selectionObservational studies reporting outcomes from irradiated and non-irradiated patients were eligible for inclusion as were randomised controlled trials (RCTs) and controlled clinical trials (CCTs) assessing irradiated patients submitted to different implant-based treatment protocols.Data extraction and synthesisScreening of titles, abstracts and full texts was by two reviewers, with disagreements resolved through discussion, consensus, or failing this by consultation with a third reviewer. Data extraction was in duplicate and attempts were made to contact authors for missing data. Risk of bias was assessed using adapted versions of the Cochrane Collaborations tool (for RCTs and CCTs) and the Newcastle-Ottawa scale for observational studies.ResultsFifteen trials with 10,150 implants were included with 1,689 (14.3%) placed in irradiated mouths. There were 13 case series and two RCTs. three of the studies were on hyperbaric oxygen (HBO) therapy. Neither of the RCTs was rated as low risk of bias. Mean survival rates ranged from 46.3% to 98% with pooled estimates showing that implant failure was statistically significantly higher in irradiated patients compared to patients who had not undergone radiotherapy (an increase of 174%) with a risk ratio of 2.74 (95% confidence interval {CI}: 1.86, 4.05; p<0.00001). In maxillary sites, the risk ratio was 5.96 (95% CI:2.71, 13.12;p<0.00001) with the risk of loss increasing to 496%. Hyperbaric oxygen therapy did not reduce the risk of implant failure showing a risk ratio of 1.28 (95% CI:0.19, 8.82).ConclusionsIrradiation of the head was linked to increased failure rate of implants compared to failure rates in patients who had not undergone radiotherapy. The failure rate was higher in the maxilla and HBO therapy did not improve implant survival.

Study suggests dentine bonding agents provided better relief from dentine hypersensitivity than a desensitising toothpaste.

Study designRandomised, controlled, single-blind, three-arm parallel-group trial set in general dental practice with a single general dental practitioner operator/assessor.InterventionSeventy-five adult patients, with basic periodontal examination scores of 0 in all sextants, good oral hygiene, at least one sensitive tooth (not diagnosed as pulpitis) and willing to comply with the trial regime were entered into the trial and randomised. Seventy-two participants completed the study. The three interventions were; non-desensitising toothpaste (Colgate Cavity Protection Regular, Colgate-Palmolive, USA), desensitising toothpaste (Colgate Sensitive Fresh Stripe, Colgate-Palmolive, USA) and dentine bonding agent (Seal and Protect, Denpsly, USA). The non-desensitising toothpaste and desensitising toothpastes were provided to the subjects for use at home but dentine bonding agent was applied in the surgery.Outcome measureDentinal hypersensitivity was measured using a participant completed Visual Analogue Scale (VAS) at baseline, two weeks, three months and six months. At baseline and six months a standardised air blast to the buccal cervical root stimulus was used with the VAS. At two weeks and at three months participants self-completed the VAS at home with no stimulus.ResultsAlthough there was a reduction in dentinal hypersensitivity over time for all three groups, dentinal hypersensitivity reduced significantly (p<0.0001) in both desensitising toothpaste and dentine bonding agent groups. The mean VAS scores in the dentine bonding agent group were statistically significantly lower when compared to both non-desensitising toothpaste (p<0.001) and desensitising toothpaste (p<0.001). In addition, mean scores for non-desensitising toothpaste were higher than desensitising toothpaste (p<0.05).ConclusionsDentine bonding agents provided the greatest improvement in dentinal hypersensitivity at two weeks and six months. This reduction was greater than that achieved with the desensitising and non-desensitising toothpastes tested.

The use of chlorhexidine in the prevention of alveolar osteitis after third molar extractions

Data sourcesCochrane Central Register of Controlled Trials (CENTRAL), Medline through PubMed, Scopus, Science Direct, ISI Web of Science, Evidence-Based Dentistry, ClinicalTrials.gov, the European Union Clinical Trials Register, the Spanish General University Board database of doctoral theses in Spain (TESEO), the Spanish National Research Council (CSIC) bibliographic databases, and the Spanish Medical Index (IME).Study selectionRandomised controlled trials (RCTs) (with or without placebo) of patients of any age or gender who underwent maxillary or mandibular third molar extractions. Studies were required to have analysed the efficacy of only chlorhexidine in any concentration, formulation or treatment regimen for preventing alveolar osteitis (AO). There was no language restriction.Data extraction and synthesisData extraction was carried out independently by two researchers, and a third researcher was consulted in case of disagreements. When explicit data were not stated in the text, they were calculated using data from the tables where possible. In addition, authors were contacted to obtain any necessary missing information. Datasets were assessed for heterogeneity, and meta-analysis was conducted on homogenous datasets. Publication bias was assessed through funnel plots. The research was conducted and is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.ResultsTwenty-three studies published from 1979 to 2015, corresponding to 18 trials (16 parallel-group and two split-mouth RCTs), that reported on 2,824 third molar extractions (1,458 in experimental group and 1,366 in control group) were included. The overall relative risk (RR) was 0.53 (95% CI, 0.45-0.62; P<.0001). There was evidence of low heterogeneity (I2 = 9.3%; P = 0.336 by X2 test). The number needed to treat was eight (95% CI, 7-11). There were no differences between chlorhexidine rinse (RR = 0.58; 95% CI, 0.47-0.71) and gel (RR = 0.47; 95% CI, 0.37-0.60) for the prevention of AO after third molar extractions. Chlorhexidine did not cause more adverse reactions than placebo.ConclusionsThe use of chlorhexidine, in any formulation (rinse or gel), concentration (0.12% or 0.20%), or regimen (before, during and/or after surgery), is efficacious and effective in preventing AO in patients who have undergone third molar extraction. The findings showed that in order to prevent one case of AO, eight patients would have to be treated with chlorhexidine. Chlorhexidine gel was found to be moderately more efficacious than the rinse formulation.

Interventions for treating cavitated or dentine carious lesions

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the clinical and cost-effectiveness of interventions (non-selective, selective or stepwise carious tissue removal, sealing of carious lesions using sealant materials or preformed metal crowns, 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.

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

BackgroundThere 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.MethodsTo 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.DiscussionThe 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 registrationCOMET (http://www.comet-initiative.org/studies/details/265?result=true). Registered on August 2012.

Outcome measures in Cochrane reviews and protocols for the prevention and treatment of periodontal disease

Background Periodontal disease (gum disease) is the most common oral disease to affect adults. The importance of core outcome sets for effectiveness trials is well established. However, despite the significant health and economic burden there is still great debate in the field as to the most appropriate clinical outcomes to measure when investigating the effectiveness & cost effectiveness of interventions. The recently published Scottish Dental Clinical Effectiveness Programme Guidelines “Prevention and Treatment of Periodontal Diseases in Primary Care” [1], highlighted the need for a set of core outcome measures for periodontal outcomes. This study was conducted to assess the variability of outcome measures reported in periodontal Cochrane reviews and protocols prior to the development of a set of core outcomes involving patients and key stakeholders.

Interventions for caries in primary teeth; mapping reported outcomes in clinical trials over the last 30 years

Background Dental caries (tooth decay) is the most prevalent disease in school age children and carries a burden of pain and infection. Clinical trials investigating interventions (fillings and other caries management techniques) to mitigate these have no agreed core outcome set making research design difficult and complicating evidence synthesis. The first step in addressing these issues is to map the current status.

Four implant bar-connected implants sufficient to support a maxillary overdenture

DesignRandomised controlled trial.InterventionEdentulous patients aged at least 18 years with lack of retention and stability of the upper denture and lower denture were randomised to receive a maxillary overdenture supported by either four or six bar-connected implants.Outcome measureThe primary outcome measure was change of radiographic bone level. Secondary outcome measures were implant survival, overdenture survival and soft tissue conditions (plaque index, presence of calculus, gingiva index, sulcus bleeding index and pocket probing depth). These were scored at placement of the overdenture and after 12 months of loading. Patient satisfaction was also scored at baseline and at 12 months.ResultsForty-nine patients (one drop out) completed the one year follow-up. Mean marginal bone resorption was 0.24 ± 0.32 mm in the four implants group and 0.25 ± 0.29 mm in the six implants group. Implant survival was 100% in the four implants group and 99.3% in the six implants group (one implant lost). Overdenture survival was 100% in both groups. There were no differences in the soft tissue outcomes between the groups. Patient satisfaction had improved in both groups.ConclusionsAfter one year a bar-connected maxillary overdenture on four or six implants results in a comparable treatment outcome with high implant survival, healthy peri-implant tissues and high patient satisfaction. For reasons of cost-effectiveness, treatment with four bar-connected implants to support a maxillary overdenture is preferred.