14 research outputs found

    Cariology Clinical Trials:What Are We-and What Should We Be-Looking At?

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    Randomized control trial (RCT) methodology has compared interventions for the prevention and management of dental caries since the late 1960s. Despite almost 50 years and evidence of significant wastage within the wider biomedical research field, there has been little investigation into what works well and where weaknesses lie. This paper aims to draw attention to areas for improvement within cariology clinical trial methodology by summarizing systematic reviews on interventions and outcomes, and using examples to illustrate some challenges with intervention delivery fidelity, outcome analyses, and intervention co-production. Trial design stage choices are critical to ensure that optimum information is obtained when testing interventions. Intervention choice, outcome choice, and analyses are particularly important, and cariology trials have specific issues associated with them. A systematic search and review of cariology RCTs found 650 RCT reports. Social Network Analysis of interventions revealed a high degree of separation between prevention and management trials, gaps in clinically important comparisons, and a tendency for there to be comparisons within groups; e.g., comparison of interventions within the same, rather than different, levels of invasiveness. Outcomes measured for the same trial reports show: a focus on restoration performance and individual/population caries burden; the growing use of carious lesion activity and economic-related outcomes; and sparse, although an increase in the use of, patient-reported/patient-centered outcomes. Fidelity of adherence to complex interventions can be challenging to measure but is important in interpreting trial findings. Involving target populations in intervention design, delivery, and relating it to the planned rollout, are opportunities to ensure intervention relevance and improved uptake. Outcomes analyses should consider the minimum clinically important differences and outcome relevance measures for the target population. Factors underlying trialists’ comparator and outcome choices need to be identified, and there is a need to ensure that a minimum dataset of outcomes allow for combination and comparisons of trial data for systematic review

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

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    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

    Dental caries experience, care index and restorative index in children with learning disabilities and children without learning disabilities; a systematic review and meta-analysis

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    Background Children with learning disabilities (CLD) have worse health outcomes than children with no learning disabilities (CNLD). This systematic review compared caries experience and met dental care need for CLD to CNLD using Decayed, Missing, Filled Permanent Teeth (DMFT) and decayed, missing/extracted, filled primary teeth (dmft/deft), care index (CI), and restorative index (RI) values. Methods Without date or language restrictions four databases were searched for; cross-sectional studies comparing caries experience and CI/ RI in CLD matched to groups of CNLD. Screening and data extraction were carried out independently and in duplicate. Risk of bias was assessed using the Newcastle-Ottawa Scale. Meta-analyses were carried out (random effects model). Results There were 25 articles with 3976 children (1 to 18 years old), from 18 countries, fitting the inclusion criteria. Children with; Down syndrome were investigated in 11 studies, autism in 8 and mixed learning disabilities in 6. The overall mean DMFT for CLD was 2.31 (standard deviation±1.97; range 0.22 to 7.2) and for CNLD was 2.51 (±2.14; 0.37 to 4.76). Using standardised mean difference (SMD), meta-analysis showed no evidence of a difference between CLD and CNLD (n = 16 studies) for caries experience (SMD = -0.43; 95%CI = -0.91 to 0.05). This was similar for sub-groups of children with autism (SMD = -0.28; 95%CI = 1.31 to 0.75) and mixed disabilities (SMD = 0.26; 95%CI = -0.94 to 1.47). However, for children with Down syndrome, caries experience was lower for CLD than CNLD (SMD = -0.73; 95%CI = -1.28 to − 0.18). For primary teeth, mean dmft/deft was 2.24 for CLD and 2.48 for CNLD (n = 8 studies). Meta-analyses showed no evidence of a difference between CLD and CNLD for caries experience across all disability groups (SMD = 0.41; 95% CI = -0.14 to 0.96), or in sub-groups: Down syndrome (SMD = 0.55; 95%CI- = − 0.40 to 1.52), autism (SMD = 0.43; 95%CI = -0.53 to 2.39) and mixed disabilities (SMD = -0.10; 95%CI = -0.34 to 0.14). The studies’ risk of bias were medium to high. Conclusion There was no evidence of a difference in caries levels in primary or permanent dentitions for CLD and CNLD. This was similar for learning disability sub-groups, except for Down syndrome where dental caries levels in permanent teeth was lower. Data on met need for dental caries was inconclusive

    Sealing caries in primary molars: Randomized control trial, 5-year results

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    The Hall Technique (HT) is a method for managing carious primary molars. Decay is sealed under pre-formed metal crowns without any caries removal, tooth preparation, or local anesthesia. The aim of this study was to compare HT clinical/radiographic failure rates with General Dental Practitioners’ (GDPs) standard (control) restorations. We conducted a split-mouth, randomized control trial (132 children, aged 3-10 yrs, GDPs n = 17) in Scotland. There were 264 study teeth with initial lesions, 42% of which were radiographically > half-way into dentin, and 67% of which had Class II restorations. Teeth were randomized to HT (intervention) or GDPs’ usual treatment (control). Annual clinical/radiographic follow-up data were recorded. Ninety-one patients (69%) had 48 months’ minimum follow-up. At 60 months, ‘Major’ failures (irreversible pulpitis, loss of vitality, abscess, or unrestorable tooth) were recorded: HT, 3 (3%); control restorations, 15 (16.5%) (p = 0.000488; NNT 8); and ‘Minor’ failures (reversible pulpitis, restoration loss/wear/fracture; or secondary caries): HT, 4 (5%); control restorations, 38 (42%) (p < 0.000001; NNT 3). Overall, there were follow-up data for 130 patients (2-60 mos): ‘Major’ failures: HT, 3 (2%); control restorations, 22 (17%) (p = 0.000004; NNT 7); and ‘Minor’ failures, HT, 7 (5%); control restorations, 60 (46%) (p < 0.000001; NNT 3). Sealing in caries by the Hall Technique statistically, and clinically, significantly outperformed GDPs’ standard restorations in the long term (Trial registration no. ISRCTN 47267892)

    Prevalence of orofacial clefts in Saudi Arabia and neighboring countries: A systematic review

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    Cleft lip and/or palate are among the most common birth defects in the world. The prevalence of these conditions varies considerably across geographic areas and ethnic groups.ObjectiveThe aim of this study was to carry out a systematic review and appraisal of the literature on the prevalence of cleft lip and/or palate in Saudi Arabia and comparable Middle Eastern countries.Materials and methodsAll published articles on orofacial clefts (OFC) in Saudi Arabia and its bordering countries in the Middle East with similar and comparable population characteristics were reviewed in July 2010.ResultsAfter reviewing the articles, only eight matched the inclusion criteria. Three studies were carried out in two regions in Saudi Arabia (Riyadh and Al-Qaseem). The other five studies were set in Dubai, Oman, and Jordan. The prevalence of cleft lip and/or palate reported in these studies varied greatly from 0.3 to 2.4 per 1000 live births. The birth prevalence of orofacial clefts in males was reported to be higher than in females. The isolated cleft palate prevalence was reported to be higher in females in most of the studies.ConclusionThe eightfold variation in the prevalence of orofacial clefts between highest and lowest prevalence is likely to be due, at least in part, to problems with ascertainment, but there may also be underlying genetic or environmental factors that require further investigation
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