Participant recruitment to FiCTION, a primary dental care trial – survey of facilitators and barriers

Objective To identify reasons behind a lower than expected participant recruitment rate within the FiCTION trial, a multi-centre paediatric primary dental care randomised controlled trial (RCT). Subjects (materials) and methods An online survey, based on a previously published tool, consisting of both quantitative and qualitative responses, completed by staff in dental practices recruiting to FiCTION. Ratings from quantitative responses were aggregated to give overall scores for factors related to participant recruitment. Qualitative responses were independently grouped into themes. Results Thirty-nine anonymous responses were received. Main facilitators related to the support received from the central research team and importance of the research question. The main barriers related to low child eligibility rates and the integration of trial processes within routine workloads. Conclusions These findings have directed strategies for enhancing participant recruitment at existing practices and informed recruitment of further practices. The results help provide a profile of the features required of practices to successfully screen and recruit participants. Future trials in this setting should consider the level of interest in the research question within practices, and ensure trial processes are as streamlined as possible. Research teams should actively support practices with participant recruitment and maintain enthusiasm among the entire practice team

Restorative Thresholds for Carious Lesions:Systematic Review and Meta-analysis

Current evidence supports noninvasive/nonrestorative treatment of “early” carious lesions: those confined to enamel or reaching the enamel-dentin junction. The extent that dentists’ thresholds for intervening restoratively have changed with this evidence is unknown. This systematic review aimed to determine dentists’ and therapists’ current lesion threshold for carrying our restorative interventions in adults/children and primary/permanent teeth. Embase, Medline via PubMed, and Web of Science were searched for observational studies, without language, time, or quality restrictions. Screening and data extraction were independent and in duplicate. Random-effects meta-analyses with subgroup and meta-regression analysis were performed. Thirty studies, mainly involving dentists, met the inclusion criteria. There was heterogeneity in sampling frames, methods, and scales used to investigate thresholds. The studies spanned 30 y (1983–2014), and sample representativeness and response bias issues were likely to have affected the results. Studies measured what dentists said they would do rather than actually did. Studies represented 17 countries, focusing mainly on adults (n = 17) and permanentteeth (n = 24). For proximal carious lesions confined to enamel (not reaching the enamel-dentin junction), 21% (95% confidence interval [CI], 15%–28%) of dentists/therapists would intervene invasively. The likelihood of a restorative intervention almost doubled (risk ratio, 1.98; 95% CI, 1.68–2.33) in high caries risk patients. For proximal lesions extending up to the enamel-dentin junction, 47% (95% CI, 39%–55%) of dentists/therapists would intervene restoratively. For occlusal lesions with enamel discoloration/cavitation but no clinical/radiographic dentin involvement, 12% (95% CI, 6%–22%) of dentists/therapists stated they would intervene, increasing to 74% (95% CI,56%–86%) with dentin involvement. There was variance between countries but no significant temporal trend. A significant proportion of dentists/therapists said they would intervene invasively (restoratively) on carious lesions where evidence and clinical recommendations indicate less invasive therapies should be used. There is great need to understand decisions to intervene restoratively and to find implementation interventions that translate research evidence into clinical practice

The Hall Technique 10 years on: its effect and influence

Dental caries in early childhood can have a very significant effect not only on the oral health of young children but on their quality of life and that of their families. Added to this are the long-term infective risks to the host of untreated caries in primary teeth but also the risk of damage to successor permanent teeth. Traditional restoration of damaged primary teeth has been shown to have only moderate outcomes depending on the techniques and materials used and the ability of children to cooperate because of age or other factors. The Hall technique has outperformed other techniques in randomised clinical trials. In this Opinion Article I will take a look back at the Innes et al. paper, first published in this Journal in 2006, that introduced the Hall Technique and the subsequent scientific literature which provided us with high quality scientific evidence of the efficacy of the technique. I will evaluate how this new technique has affected the management of early childhood caries and hence its influence on wider oral and general health

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

Abstract 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)

Cost-effectiveness of child caries management: results from the FiCTION RCT

Background: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA).Methods: Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.Results: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P.Conclusions: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%.Trial registration: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).</p

Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial)

Background: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA). Methods: Data on costs were collected via case report forms completed by clinical staff at every visit. The coprimary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. Results: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (− 0.06; 97.5% CI: − 0.14 to 0.02) and fewer episodes of dental pain and/or infection (− 0.14; 97.5% CI: − 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P. Conclusions: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%. Trial registration: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047)

The effect of premature extraction of primary teeth on the subsequent need for orthodontic treatment.

AIM: To investigate if premature extraction of primary teeth was associated with orthodontic need in the permanent dentition. STUDY DESIGN: This was a case-control study based on retrospective dental records. METHODS: As part of NHS (UK) Dental Epidemiology Programme a sample of 366, 12-year-old children from Bradford and Airedale were examined. The survey collected data on patient demographics, dental health status including orthodontic need. Data linkage was undertaken for those children participating in the NHS Dental Epidemiology Programme who had previously accessed the local Salaried Dental Service (SDS). For these children, retrospective dental information was collected about premature extraction of primary teeth. RESULTS: From the 366 children who were surveyed, 116 children had received treatment at the local SDS in the past. Significantly more children from ethnic minorities, low socioeconomic backgrounds and high caries rate (p < 0.001) were seen in the SDS. For the 107 children who attended SDS, an increased total number of primary teeth extractions was positively associated with orthodontic need (odds ratio:1.18, CI -1.01 to 1.37). STATISCTICS: Multilevel modelling was undertaken to identify variables associated with orthodontic need. CONCLUSIONS: In the study group, orthodontic need was significantly associated with the number of primary teeth extracted

Prognostic model to predict postoperative acute kidney injury in patients undergoing major gastrointestinal surgery based on a national prospective observational cohort study.

Background: Acute illness, existing co-morbidities and surgical stress response can all contribute to postoperative acute kidney injury (AKI) in patients undergoing major gastrointestinal surgery. The aim of this study was prospectively to develop a pragmatic prognostic model to stratify patients according to risk of developing AKI after major gastrointestinal surgery. Methods: This prospective multicentre cohort study included consecutive adults undergoing elective or emergency gastrointestinal resection, liver resection or stoma reversal in 2-week blocks over a continuous 3-month period. The primary outcome was the rate of AKI within 7 days of surgery. Bootstrap stability was used to select clinically plausible risk factors into the model. Internal model validation was carried out by bootstrap validation. Results: A total of 4544 patients were included across 173 centres in the UK and Ireland. The overall rate of AKI was 14·2 per cent (646 of 4544) and the 30-day mortality rate was 1·8 per cent (84 of 4544). Stage 1 AKI was significantly associated with 30-day mortality (unadjusted odds ratio 7·61, 95 per cent c.i. 4·49 to 12·90; P < 0·001), with increasing odds of death with each AKI stage. Six variables were selected for inclusion in the prognostic model: age, sex, ASA grade, preoperative estimated glomerular filtration rate, planned open surgery and preoperative use of either an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Internal validation demonstrated good model discrimination (c-statistic 0·65). Discussion: Following major gastrointestinal surgery, AKI occurred in one in seven patients. This preoperative prognostic model identified patients at high risk of postoperative AKI. Validation in an independent data set is required to ensure generalizability

The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months

<p>Abstract</p> <p>Background</p> <p>Scotland has high levels of untreated dental caries in primary teeth. The Hall Technique is a simplified method of managing carious primary molars using preformed metal crowns (PMCs) cemented with no local anaesthesia, caries removal or tooth preparation. This study compared the acceptability of the Hall Technique for children, their carers, and dentists, and clinical outcomes for the technique, with conventional restorations.</p> <p>Methods</p> <p>General dental practice based, split mouth, randomized controlled trial (132 children, aged 3–10). General dental practitioners (GDPs, n = 17) in Tayside, Scotland (dmft 2.7) placed conventional (Control) restorations in carious primary molars, and Hall Technique PMCs on the contralateral molar (matched clinically and radiographically). Dentists ranked the degree of discomfort they felt the child experienced for each procedure; then children, their carers and dentists stated which technique they preferred. The teeth were followed up clinically and radiographically.</p> <p>Results</p> <p>128 conventional restorations were placed on 132 control teeth, and 128 PMCs on 132 intervention teeth. Using a 5 point scale, 118 Hall PMCs (89%) were rated as no apparent discomfort up to mild, not significant; for Control restorations the figure was 103 (78%). Significant, unacceptable discomfort was recorded for two Hall PMCs (1.5%) and six Control restorations (4.5%). 77% of children, 83% of carers and 81% of dentists who expressed a preference, preferred the Hall technique, and this was significant (Chi square, p < 0.0001). There were 124 children (94% of the initial sample) with a minimum follow-up of 23 months. The Hall PMCs outperformed the Control restorations:</p> <p>a) 'Major' failures (signs and symptoms of irreversible pulpal disease): 19 Control restorations (15%); three Hall PMCs (2%) (P < 0.000);</p> <p>b) 'Minor' failures (loss of restoration, caries progression): 57 Control restorations (46%); six Hall PMCs (5%) (P < 0.000)</p> <p>c) Pain: 13 Control restorations (11%); two Hall PMCs (2%) (P = 0.003).</p> <p>Conclusion</p> <p>The Hall Technique was preferred to conventional restorations by the majority of children, carers and GDPs. After two years, Hall PMCs showed more favourable outcomes for pulpal health and restoration longevity than conventional restorations. The Hall Technique appears to offer an effective treatment option for carious primary molar teeth.</p> <p>Trial registration number</p> <p>Current Controlled Trials ISRCTN47267892 – A randomized controlled trial in primary care of a novel method of using preformed metal crowns to manage decay in primary molar teeth: the Hall technique.</p