Oral health-related quality of life among people living with HIV and HIV-negative adults in Kigali, Rwanda: a comparative cross-sectional study.

BACKGROUND: Assessing health-related quality of life has become integral to people living with HIV (PLHIV) follow-up. However, there is a lack of data regarding the impact of oral health on quality of life, known as Oral health-related quality of life (OHRQoL) among PLHIV compared to HIV-negative individuals in Rwanda. AIM: The study aimed to assess OHRQoL among PLHIV compared to HIV-negative counterparts in Kigali, Rwanda. METHODS: The Oral Health Impact Profile short version (OHIP-14) questionnaire was interviewer-administered to 200 PLHIV and 200 HIV-negative adults (≥ 18 years old) at an HIV clinic of Kigali Teaching Hospital (CHUK). Socio-demographic characteristics, including age, sex, occupation, and socioeconomic status (SES) of participants, were collected using a survey questionnaire. A 4-point Likert scale was used to assess the frequency of oral impacts for all 14 items within 7 domains of the OHIP tool. The descriptive statistics were used to see frequencies and percentages of OHRQoL among PLHIV and HIV-negative persons, respectively. The Chi-square test was used to determine the association of OHRQoL with caries (DMFT) and periodontal disease (CPITN) among PLHIV compared to HIV-negative individuals. RESULTS: The results revealed a higher prevalence of PLHIV with poor OHRQoL than HIV-negative individuals in 5 domains and almost all items of OHIP-14 except for the OHIP 3 (found it uncomfortable to eat any foods because of problems with teeth or mouth) and OHIP-14 (being totally unable to function because of problems with teeth or mouth). The findings showed statistically significant results (p ≤ 0.05) for the OHIP1 item "trouble pronouncing any word," with a prevalence of 2.5% (n = 11) and 2.25% (n = 9) in PLHIV and HIV-negative, respectively. Also, PLHIV had a significantly higher prevalence, 2.75% (n = 11) for the OHIP 13 item "life not satisfying due to teeth and mouth problems compared to HIV-negative individuals 2% (8) p ≤ 0.05. Moreover, dental caries was significantly associated with poor OHRQoL among PLHIV and HIV-negative adults and for all 14 items of the OHIP tool. Periodontal disease was not significantly associated with OHRQoL among PLHIV and HIV-negative adults. CONCLUSION: This study revealed poor OHRQoL among PLHIV compared to HIV-negative adults. There is a need for further longitudinal studies to investigate the OHRQoL in Rwanda, especially among PLHIV. It is essential to include oral health care as one of the components of the medical health care programs for PLHIV in Rwanda.

Is there an association between viral load, CD4 count, WHO staging, and dental caries in HIV-positive children?

BACKGROUND: Few studies have investigated an association between CD4 counts, viral load (VL), WHO staging, and caries among HIV-positive (HIV+) children on HAART therapy (>12 months). AIM: To determine the strength of association between CD4 counts, WHO staging, VL, and dental caries. DESIGN: This cross-sectional analytical study comprised of 355 HIV + children, aged 4-12 years, attending a hospital in Johannesburg, South Africa. Demographic and clinical data such as decayed (d,D), missing (m,M), filled teeth (f,F) [dmft/DMFT], CD4 counts, and WHO staging were collected. Correlation and regression analyses were done to test for associations. RESULTS: Caries prevalence for this cohort of children was 57%. The dmft score for the primary dentition was 4.36 (SD 4.87) and DMFT for secondary dentition was 0.58 (SD 1.49). Pearson's correlation analyses showed significant association between VL and CD4 count (P = .003) and VL and WHO stage (P = .007). Weak associations were noted between caries (d, D) and VL, CD4 count, and WHO stage of disease for correlation and regression analyses. CONCLUSION: There appears to be no substantial evidence of any significant association between the presence of caries among HIV + children and CD4 counts, viral load, and WHO clinical stage of the disease.

WITHDRAWN: Dental fillings for the treatment of caries in the primary dentition.

BACKGROUND: Childhood caries (tooth decay) consists of a form of tooth decay that affects the milk teeth (also known as baby or primary teeth) of children. This may range from tooth decay in a single tooth to rampant caries affecting all the teeth in the mouth. Primary teeth in young children are vital to their development and every effort should be made to retain these teeth for as long as is possible. Dental fillings or restorations have been used as an intervention to repair these damaged teeth. Oral health professionals need to make astute decisions about the type of restorative (filling) material they choose to best manage their patients with childhood caries. This decision is by no means an easy one as remarkable advances in dental restorative materials over the last 10 years has seen the introduction of a multitude of different filling materials claiming to provide the best performance in terms of durability, aesthetics, symptom relief, etc when placed in the mouth. This review sought to compare the different types of dental materials against each other for the same outcomes. OBJECTIVES: The objective of this review was to compare the outcomes (including pain relief, survival and aesthetics) for restorative materials used to treat caries in the primary dentition in children.  Additionally, the restoration of teeth was compared with extraction and no treatment. SEARCH METHODS: Electronic searches of the following databases were undertaken: the Cochrane Oral Health Group's Trials Register (up to January 2009); CENTRAL (The Cochrane Library 2009, Issue1); MEDLINE (1966 to January 2009); EMBASE (1996 to January 2009); SIGLE (1976 to 2004); and conference proceedings on early childhood caries, restorative materials for paediatric dentistry, and material sciences conferences for dental materials used for children's dentistry (1990 to 2008). The searches attempted to identify all relevant studies irrespective of language.Additionally, the reference lists from articles of eligible papers were searched, handsearching of key journals was undertaken, and personal communication with authors and manufacturers of dental materials was initiated to increase the pool of suitable trials (both published and unpublished) for inclusion into this review. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-randomised controlled trials with a minimum period of 6 months follow up were included. Both parallel group and split-mouth study designs were considered. The unit of randomisation could be the individual, group (school, school class, etc), tooth or tooth pair. Included studies had a drop-out rate of less than 30%. The eligible trials consisted of young children (children less than 12 years) with tooth decay involving at least one tooth in the primary dentition which was symptomatic or symptom free at the start of the study. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two review authors. Disagreements were resolved by consultation with a third review author. Authors were contacted for missing or unclear information regarding randomisation, allocation sequence, presentation of data, etc. A quality assessment of included trials was undertaken. The Cochrane Collaboration statistical guidelines were followed for data analysis. MAIN RESULTS: Only three studies were included in this review. The Fuks 1999 study assessed the clinical performance of aesthetic crowns versus conventional stainless steel crowns in 11 children who had at least two mandibular primary molars that required a crown restoration. The outcomes assessed at 6 months included gingival health (odds ratio (OR) 0.3; 95% confidence interval (CI) 0.01 to 8.32), restoration failure (OR 3.29; 95% CI 0.12 to 89.81), occlusion, proximal contact and marginal integrity. The odds ratios for occlusion, proximal contact and marginal integrity could not be estimated as no events were recorded at the 6-month evaluation. The Donly 1999 split-mouth study compared a resin-modified glass ionomer (Vitremer) with amalgam over a 36-month period. Forty pairs of Class II restorations were placed in 40 patients (21 males; 19 females; mean age 8 years +/- 1.17; age range 6 to 9 years). Although the study period was 3 years (36 months), only the 6- and 12-month results are reported due to the loss to follow up of patients being greater than 30% for the 24- and 36-month data. Marks 1999a recruited 30 patients (age range 4 to 9 years; mean age 6.7 years, standard deviation 2.3) with one pair of primary molars that required a Class II restoration. The materials tested were Dyract (compomer) and Tytin (amalgam). Loss to follow up at 24 and 36 months was 20% and 43% respectively. This meant that only the 24-month data were useable. For all of the outcomes compared in all three studies, there were no significant differences in clinical performance between the materials tested.No studies were found that compared restorations versus extractions or no treatment as an intervention in children with childhood caries. AUTHORS' CONCLUSIONS: It was disappointing that only three trials that compared three different types of materials were suitable for inclusion into this review. There were no significant differences found in all three trials for all of the outcomes assessed. Well designed, randomised controlled trials comparing the different types of filling materials for similar outcomes are urgently needed in dentistry. There was insufficient evidence from the three included trials to make any recommendations about which filling material to use.

A Test Method for Identifying Selection Bias Risk in Prospective Controlled Clinical Therapy Trials Using the I2 Point Estimate.

OBJECTIVES: A test method is proposed for identifying potential selection bias risk in single prospective controlled clinical therapy trials that can be applied by trial reviewers. METHODS: The method is described in detail and was tested on eight randomised controlled trials (RCTs) with reported negative Berger-Exner test results as negative and on eight prospective, controlled cohort studies as positive controls. All 16 studies were identified by systematic literature search. RESULTS: The test method yielded negative results for all RCTs and positive results for six out of the eight cohort studies. CONCLUSION: All test results remained within the expected limits for both study types, suggesting a reasonably high accuracy for correctly identifying selection bias risk. However, the method does not provide the possibility to establish whether such bias risk has actually altered trial outcomes. Instead, a positive test result may provide an empirical basis for rating a trial as of high selection bias risk during trial appraisal.

Trial Number and Sample Size Do Not Affect the Accuracy of the I2-Point Estimate for Testing Selection Bias Risk in Meta-Analyses.

Aim This study aims to establish the test sensitivity and specificity of the I2-point estimate for testing selection bias in meta-analyses under the condition of large versus small trial sample size and large versus small trial number in meta-analyses and to test the null hypotheses that the differences are not statistically significant. Material and methods Simulation trials were generated in MS Excel (Microsoft Corp., Redmond, WA), each consisting of a sequence of subject ID (accession) numbers representing trial subjects, a random sequence of allocation to group A or B, and a random sequence of a simulated baseline variable ("age") per subject, ranging from 50 to 55. These simulation trials were included in five types of meta-analyses with large/small numbers of trials, as well as trials with large and small sample sizes. Half of the meta-analyses were artificially biased. All meta-analyses were tested using the I2-point estimate. The numbers of true positive (TP), false positive (FP), false negative (FN), and true negative (TN) test results were established. From these, the test sensitivity and specificity were computed for each of the meta-analysis types and compared. Results All non-biased meta-analyses yielded true negative, and all biased meta-analyses yielded true positive test results, regardless of trial number and trial sample size. No false positive or false negative test results were observed. Accordingly, test sensitivities and specificities of 100% for all meta-analysis types were established, and thus, both null hypotheses failed to be rejected. Conclusion The results suggest that trial number and sample size in a baseline variable meta-analysis do not affect the test accuracy of the I2-point estimate.

Application of the Composite Quality Score (CQS-2B) versus Cochrane's Risk of Bias tool (Version 2) in systematic reviews of clinical trials - an exploratory study.

Objectives: To explore whether systematic review conclusions generated from Cochrane's second version of its Risk of Bias tool (RoB 2) for trial appraisal differ when the Composite Quality Score, Version 2.B (CQS-2B) is used instead and to develop a testable hypothesis based on these findings. Methods: PubMed was searched for one single systematic review. From the review's accepted trials, data concerning effect estimates and overall bias risk according to the RoB 2 tool were extracted. All trial reports were appraised again using the CQS-2B. Datasets were stratified according to overall bias risk (RoB 2) or corroboration (C-) level (CQS-2B). The effect estimates from trials with 'low bias risk' (RoB 2) and with highest C-level (CQS-2B) were pooled separately. These pooled effect estimates were statistically and all clinical conclusions qualitatively compared. Results: The pooled effect estimates for trials with 'low bias risk' (RoB 2) were -0.07, 95% CI: -0.10 to -0.04 (I2 = 0.0%) and for the highest C-levels (CQS-2B) 0.08, 95% CI: -0.12 to -0.04 (I2 = 57.0%). The difference was statistically not significant (p = 0.70). Contrary to the RoB 2 tool, no clinical conclusions in line with the CQS-2B were made, because the effect estimates were judged to be erroneously overestimated, due to high risk of bias. Conclusion: A testable hypothesis was generated suggesting that trial appraisal using the CQS-2B may provide more conservative conclusions based on similar data than with the RoB 2 tool.

Correction: Exploring reasons why South African dental therapists are leaving their profession: A theory-informed qualitative study.

[This corrects the article DOI: 10.1371/journal.pone.0293039.].

Allocation concealment appraisal of clinical therapy trials using the extended Composite Quality Score (CQS-2)-An empirically based update.

Objectives: The objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials. Methods: Meta-analyses of trials with inadequate allocation concealment were tested for in-between trial heterogeneity (I2 > 0) due to imbalances in baseline variables. Meta-analyses with positive test results were used as a basis to deduce criteria for adequate allocation concealment. The CQS-2/Criterion II was reformulated in line with the findings. Result: One suitable meta-analysis was identified. Two forest plots with data from five and four trials with inadequate/unclear allocation concealment were selected for testing. In addition, a total of five trials with adequate allocation concealment were identified. The meta-analysis test results were positive, and keywords for the judgment of adequate allocation concealment were extracted verbatim from the text of the meta-analysis. The extracted keywords indicated "central allocation" as the main criterion for adequate allocation concealment. Criterion II of the CQS-2 was revised accordingly. Conclusion: Criterion II of the CQS-2 trial appraisal tool was revised. The revised appraisal tool was specified as version CQS-2B.

The composite quality score for the appraisal of prospective controlled clinical therapy trials in systematic reviews and its limits.

Systematic reviews of prospective controlled clinical therapy trials are one of the most important sources of information in modern medicine. Besides the systematic search for and statistical pooling of current clinical trial data for a particular type of therapy, systematic reviews also have the task of appraising the quality of trial results. The quality of trial results may be diminished by low internal trial validity, due to systematic error (bias). A high risk of bias may likely cause the reported trial results to be diverted from the actual true therapeutic effect and thus render it unsuitable for clinical guidance. According to the Cochrane Collaboration, the risk of bias in clinical therapy trials should be assessed using its Risk of Bias tool, Version 2 (RoB 2). However, the tool has been established to have poor inter-rater reliability, with a limited empirical evidence base and described as complex and demanding. Against this background, the composite quality score (CQS) has been developed as a possible alternative trial appraisal tool, characterised by high epistemic rigour, empirical evidence base, inter-rater reliability and ease of use. This article presents the current evidence of the CQS and its limitations.

The Composite Quality Score (CQS) as an Appraisal Tool for Prospective, Controlled Clinical Therapy Trials: Rationale and Current Evidence.

BACKGROUND: Current evidence appraisal concepts, such as the Assessment, Development and Evaluation (GRADE) approach and Cochrane's Risk of Bias (RoB) tool, rely on assumptions related to the classic problem of inductive reasoning and may suffer from insufficient inter-rater reliability. DISCUSSION: The Composite Quality Score (CQS) has emerged as a possible trial appraisal tool that does not rely on inductive assumptions and has been shown to be of potentially very high inter-rater reliability. CONCLUSION: Although the current CQS concept is still under development, its current evidence is encouraging and justifies further study. This article presents the rationale and currently available research concerning the CQS and shows where further research is required.

Prevalence of dental caries and associated risk factors among People Living with HIV/AIDS and HIV uninfected adults at an HIV clinic in Kigali, Rwanda.

BACKGROUND: Dental caries is among the most frequent oral conditions in People Living with HIV/AIDS (PLWHA). There is a lack of baseline information on dental caries prevalence and associated risk factors among PLWHA in comparison to HIV uninfected people in Rwanda. OBJECTIVE: This study was conducted to determine the prevalence of dental caries and associated risk factors among PLWHA and HIV uninfected adults at an HIV clinic of Kigali Teaching Hospital (CHUK) in Kigali, Rwanda. METHODS: A comparative cross-sectional study was conducted among 200 PLWHA and 200 HIV uninfected adults aged 18 years and above attending an HIV clinic of CHUK. An oral examination was performed by a calibrated examiner. Dental caries were assessed using the WHO Decayed (D), Missing (M), and Filled Teeth (F) index (DMFT). Descriptive statistics, Chi-square, t-tests, and multiple binary logistic regression were used to analyze data. RESULTS: Overall, a higher prevalence (50.5%) of PLWHA had experienced dental caries (DMFT>0) compared to HIV uninfected counterparts (40.5%) (p = 0.045). The prevalence of Decayed teeth (D) was also higher (23.5%) among PLWHA compared to HIV uninfected persons (13.6%) (p = 0.011). The Mean(SD) DMFT scores among PLWHA and HIV uninfected participants were 2.28 (3.68) and 1.29 (2.21) respectively (p = 0.001). After performing multiple binary logistic regression analysis, the predictors of dental caries in PLWHA were being female (OR = 2.33; 95%CI = 1.14-4.75), frequent dental visits (OR = 4.50; 95% CI = 1.46-13.86) and detectable RNA viral load (OR = 4.50; 95% CI = 1.46-13.86). In HIV uninfected participants, the middle age range (36-45 years), and frequent dental visits were significantly associated with dental caries (OR = 6.61; 95%CI = 2.14-20.37) and (OR = 3.42; 95%CI: 1.337-8.760) respectively. CONCLUSION: The prevalence of dental caries was higher in PLWHA than in HIV uninfected counterparts. The reported higher prevalence of caries in PLWHA was associated with being female, detectable viral load, and frequent dental visits. Therefore, there is a need for effective oral health interventions specific to PLWHA in Rwanda to raise awareness of the risk of dental caries and provide preventive oral health services among this population. To ensure timely oral health care amongPLWHA, there is a need for an effort from policymakers and other stakeholders to integrate oral health care services within the HIV treatment program in Rwanda.

Validation of the Child-Oral-Health-Impact-Profile among adolescents in Johannesburg: A cross-sectional study.

BACKGROUND:  Oral health-related quality of life (OHRQol) is described as the effect of oral conditions on the overall functioning and well-being of individuals. AIM:  This study sought to determine the validity of a modified-child oral health impact profile (M-COHIP) among adolescents living with the human immunodeficiency virus (HIV) infection (ALHIV) and HIV-undiagnosed adolescents and establish the factors influencing OHRQoL among adolescents in central Johannesburg. SETTING:  Schools and HIV wellness centre in central Johannesburg. METHODS:  An interviewer-administered questionnaire was applied, followed by an oral examination. RESULTS:  A total of 504 adolescents were included in the study. The overall mean decayed teeth for permanent dentition was 1.6 (standard deviation [s.d.]: 1.99) and caries prevalence was 62.2% (n = 309). The tool's Cronbach's alpha was 0.88. The item-rest correlations were from 0.6 to 0.85 for all items. The initial exploratory factor analysis explained 76% of the total variance. The overall M-COHIP score was 59.6 (18.2). The overall modified-COHIP scores for those not in care (schools) were higher [62.88] than those of ALHIV. The poor M-COHIP scores were associated with reporting toothache, having active decay, poor oral health-self-rating, and being selected from the school site (p  0.005). CONCLUSION:  The validation study supports the use of the tool as a reliable and valid measure of OHRQoL. Future research can investigate the extent to which the tool is effective in measuring treatment outcomes and patient satisfaction.Contribution: The validated tool will be beneficial in the African context for programme assessments and overall measure of quality-of-life impacts from oral conditions.

Attrition of dental therapists in South Africa-A 42-year review.

INTRODUCTION: Dental therapists are mid-level oral healthcare providers introduced in 1977 to the South African health system to improve access to oral health services. There has, however, been anecdotal evidence of their unusually high rate of attrition that is cause for concern. AIM AND OBJECTIVES: This study aimed to determine the demographic profile and attrition rate among members of the South African Dental Therapy profession. METHODS: A retrospective time series review of records of all dental therapists who were previously registered and who are still registered with the Health Professions Council of South Africa (HPCSA) between 1977 and 2019 was conducted. RESULTS: A total of 1232 dental therapists were registered from 1977 to 2019. The majority (64%) were Africans. Most practicing dental therapists were based in KwaZulu-Natal (44%) and Gauteng (27%), which are the provinces where dental therapists are trained. The overall attrition rate between 1977 and 2019 was 40%, with a figure of 9% for the last 10 years of the study (2010 to 2019). CONCLUSION: This study has provided the first evidence of the high attrition rate of dental therapists in South Africa. The high attrition warrants further investigation to address the loss of valuable human resources from an already overburdened and under-resourced public oral health sector.

Exploring reasons why South African dental therapists are leaving their profession: A theory-informed qualitative study.

BACKGROUND: Dental therapy is a category of mid-level oral health professional that was introduced to address inequities in oral health service provision in South Africa within a constrained human resource for health context. However, low numbers of registered dental therapists and attrition threaten this strategy. AIM: This study explored reasons for this attrition, building on the Hertzberg Two-Factor Theory. METHODS: Through a qualitative exploratory study design, in-depth interviews were conducted with former dental therapists to explore their reasons for leaving the profession. They were recruited using snowball sampling. All interviews were audio recorded, transcribed verbatim, and coded in NVIVO12. A team of researchers applied thematic analysis to agree on themes and sub-themes, guided by Hertzberg's ideas of intrinsic and extrinsic factors. FINDINGS: All 14 former dental therapists interviewed expressed their passion for the profession, even though their motivations to join the profession varied. Many of their reasons for leaving aligned with extrinsic and intrinsic factors defined in Hertzberg's Two-Factor Theory. However, they also spoke about a desire for a professional identity that was recognized and respected within the oral health profession, health system, and communities. This is a novel study contribution. CONCLUSION: Dental therapist attrition in South Africa is mainly caused by job dissatisfaction and motivation issues resulting from health system level factors. While the Hertzberg Two-Factor Theory helped identify extrinsic and intrinsic factors at an individual level, we used the Human Resources for Health System Development Analytical Framework to identify solutions for dental therapist production, deployment, and retention. Addressing these issues will enhance retention and accessibility to oral health services in the country.

Inter-rater reliability of the extended Composite Quality Score (CQS-2).

Aim: To establish the inter-rater reliability of the Composite Quality Score (CQS-2) and to test the null hypothesis that it did not differ significantly from that of the first CQS version (CQS-1). Materials and methods: Four independent raters were selected to rate 45 clinical trial reports using CQS-1 and CQS-2. The raters remained unaware of each other's participation in this study until all rating had been completed. Each rater received only one rating template at a time in a random sequence for CQS-1 and CQS-2 rating. Raters completed each template and sent these back to the principal investigator. Each rater received their next template 2 weeks after submission of the completed previous template. The inter-rater reliabilities for the overall appraisal score of the CQS-1 and the CQS-2 were established by using the Brennan-Prediger coefficient (BPC). The coefficients of both CQS versions were compared by using the two-sample z-test. During secondary analysis, the BPCs for every criterion and each corroboration level for both CQS versions were established. Results: The BPC for the CQS-1 was 0.85 (95% CI: 0.64-1.00) and for the CQS-2 it was 1.00 (95% CI: 0.94-1.00), suggesting a very high inter-rater reliability for both. The difference between the two CQS versions was statistically not significant (p = 0.17). The null hypothesis was accepted. Conclusion: The CQS-2 is still under development, This study shows that it is associated with a very high inter-rater reliability, which did not statistically significantly differ from that of the CQS-1. The promising results of this study warrant further investigation in the applicability of the CQS-2 as an appraisal tool for prospective controlled clinical therapy trials.

Retention of orthodontic brackets bonded with resin-modified GIC versus composite resin adhesives--a quantitative systematic review of clinical trials.

The aim of this systematic review was to establish whether the clinical debonding (failure) rates of orthodontic brackets bonded either with resin-modified glass ionomer (RM-GIC) or with composite resin adhesive are the same. Five databases were searched for articles up to 18 November 2010. Inclusion criteria were titles/abstracts relevant to the review question and two or more arm clinical trial. Exclusion criteria were the following: no computable data recorded and subjects of both groups not followed up in the same way. From the accepted trials, datasets were analysed concerning clinical precision and internal validity. Eleven trials were accepted. From these, 15 dichotomous datasets were extracted. Relative risk with 95% confidence interval of nine datasets showed no statistically significant differences in outcome between the treatment and control group after 6 months-1.32 years. Five showed a statistically significant difference (p < 0.05), favouring resin composite bonding after 12 and 18 months. One favoured RM-GIC after 10 months. Meta-analysis found no difference in the failure rate between the two treatment groups after 12 months (RR, 1.11; 95% CI, 0.87-1.42; p = 0.40) and found in favour of composite resin adhesive after >14 months (RR, 2.25; 95% CI, 1.60-3.17; p < 0.00001). All trials had poor internal validity due to selection and detection/performance bias risk. The current evidence suggests no difference between the types of materials after 12 months but favours composite resin adhesives after a >14-month period. However, its risk of selection and detection/performance bias are high, and all results need to be regarded with caution. Further high quality randomised control trials addressing this topic are needed. The clinical relevance of this study is that RM-GIC may have the same clinical debonding (failure) rate as composite resin adhesives after 1 year when used for bonding of orthodontic brackets.

Effect of xylitol versus sorbitol: a quantitative systematic review of clinical trials.

OBJECTIVES: This study aimed to appraise, within the context of tooth caries, the current clinical evidence and its risk for bias regarding the effects of xylitol in comparison with sorbitol. METHODS: Databases were searched for clinical trials to 19 March 2011. Inclusion criteria required studies to: test a caries-related primary outcome; compare the effects of xylitol with those of sorbitol; describe a clinical trial with two or more arms, and utilise a prospective study design. Articles were excluded if they did not report computable data or did not follow up test and control groups in the same way. Individual dichotomous and continuous datasets were extracted from accepted articles. Selection and performance/detection bias were assessed. Sensitivity analysis was used to investigate attrition bias. Egger's regression and funnel plotting were used to investigate risk for publication bias. RESULTS: Nine articles were identified. Of these, eight were accepted and one was excluded. Ten continuous and eight dichotomous datasets were extracted. Because of high clinical heterogeneity, no meta-analysis was performed. Most of the datasets favoured xylitol, but this was not consistent. The accepted trials may be limited by selection bias. Results of the sensitivity analysis indicate a high risk for attrition bias. The funnel plot and Egger's regression results suggest a low publication bias risk. External fluoride exposure and stimulated saliva flow may have confounded the measured anticariogenic effect of xylitol. CONCLUSIONS: The evidence identified in support of xylitol over sorbitol is contradictory, is at high risk for selection and attrition bias and may be limited by confounder effects. Future high-quality randomised controlled trials are needed to show whether xylitol has a greater anticariogenic effect than sorbitol.

Anticariogenic effect of xylitol versus fluoride - a quantitative systematic review of clinical trials.

The objective of this study was to appraise the clinical evidence and its bias risk regarding the anticariogenic effect of xylitol in comparison with that of fluoride. Databases were searched for clinical trials up to 18 March 2011. Article inclusion criteria were as follows: caries-related primary outcomes were tested; xylitol was compared with topical fluoride in some form; two-arm (or more) clinical trial including test/control group(s); prospective study design. Article exclusion criteria were as follows: no computable data were reported; test and control groups were not followed up in the same way; chewing gum was the main form of clinical application in either group. Individual continuous datasets were extracted from accepted articles. Selection and performance/detection bias were assessed. Sensitivity analysis was used to investigate attrition bias risk. Egger's regression and funnel plot was used to investigate publication bias risk. Twelve articles were included. Of these, six were accepted and six excluded, and 21 continuous datasets were extracted. Owing to the high clinical heterogeneity, no meta-analysis was performed. The addition of xylitol to existing fluoride regimes may be beneficial in the prevention of caries. However, all identified trials were limited by potential risk of selection, performance/detection and attrition bias. The funnel plot and Egger's regression results (-2.80; 95% confidence interval -4.01, -1.58; P = 0.0001) indicated possible publication bias risk. External fluoride access may have confounded the measured anticariogenic effect of xylitol. The evidence found contains a high risk of bias and may be limited by confounder effects. Future high-quality randomised controlled trials are needed in order to provide conclusive evidence on this topic.

Extension of the Composite Quality Score (CQS) as an appraisal tool for prospective, controlled clinical therapy trials-A systematic review of meta-epidemiological evidence.

AIM: To conduct a survey of current meta-epidemiological studies to identify additional trial design characteristics that may be associated with significant over- or underestimation of the treatment effect and to use such identified characteristics as a basis for the formulation of new CQS appraisal criteria. MATERIALS AND METHODS: We retrieved eligible studies from two systematic reviews on this topic (latest search May 2015) and searched the databases PubMed and Embase for further studies from June 2015 -March 2022. All data were extracted by one author and verified by another. Sufficiently homogeneous estimates from single studies were pooled using random-effects meta-analysis. Trial design characteristics associated with statistically significant estimates from single datasets (which could not be pooled) and meta-analyses were used as a basis to formulate new or amend existing CQS criteria. RESULTS: A total of 38 meta-epidemiological studies were identified. From these, seven trial design characteristics associated with statistically significant over- or underestimation of the true therapeutic effect were found. CONCLUSION: One new criterion concerning double-blinding was added to the CQS, and the original criteria for concealing the random allocation sequence and for minimum sample size were amended.

Extent and quality of systematic review evidence related to minimum intervention in dentistry: essential oils, powered toothbrushes, triclosan, xylitol.

OBJECTIVE: To investigate extent and quality of current systematic review evidence regarding: powered toothbrushes, triclosan toothpaste, essential oil mouthwashes, xylitol chewing gum. METHODS: Five databases were searched for systematic reviews until 13 November 2010. INCLUSION CRITERIA: relevant to topic, systematic review according to title and/or abstract, published in English. Article exclusion criteria were based on QUOROM recommendations for the reporting of systematic review methods. Systematic review quality was judged using the AMSTAR tool. All trials included by reviews were assessed for selection bias. RESULTS: 119 articles were found, of which 11 systematic reviews were included. Of these, six were excluded and five accepted: one for triclosan toothpaste; one for xylitol chewing gum; two for powered toothbrushes; one for essential oil mouthwashes. AMSTAR scores: triclosan toothpaste 7; powered toothbrushes 9 and 11; xylitol chewing gum 9; essential oil mouthwashes 8. In total, 75 (out of 76) reviewed trials were identified. In-depth assessment showed a high risk of selection bias for all trials. CONCLUSIONS: The extent of available systematic review evidence is low. Although the few identified systematic reviews could be rated as of medium and high quality, the validity of their conclusions needs to be treated with caution, owing to high risk of selection bias in the reviewed trials. High quality randomised control trials are needed in order to provide convincing evidence regarding true clinical efficacy.