Quality Ratings of Randomized Controlled Trials

Author, Year, TitleRandomization Adequate?Allocation Concealment Adequate?Groups Similar at Baseline?Eligibility Criteria Specified?Outcome Assessors Masked?Care Provider Masked?Patient Masked?Reporting of Attrition, Crossovers, Adherence, and ContaminationLoss To Follow-up: Differential/HighIntention-To-Treat AnalysisPostrandomization ExclusionsOutcomes PrespecifiedFunding SourceExternal ValidityQuality Rating
Alamoudi et al 201223UnclearYesUnclearYesUnclearNoNoYesYes (very high)YesYesYesThe Deanship of Scientific Research, King Abdulaziz University, Jeddah, Saudi Arabia (Project No. 429/011-9)FairPoor
 Effects of xylitol on salivary mutans Streptococcus, plaque level, and caries activity in a group of Saudi mother-child pairs
Davies et al 200724Not randomizedUnclearYesYesUnclearUnclearUnclearNoYesNoNoYesNational Health Service Research and Development Program for Primary Dental CareFairPoor
 Challenges associated with the evaluation of a dental health promotion program in a deprived urban area
Davies et al 200525
 A staged intervention dental health promotion program to reduce early childhood caries
Kovari et al 200326NRNRUnclearYesUnclearNoNoYesNoYesNoYesNot reportedLimitedFair
 Use of xylitol chewing gum in daycare centers: a follow-up study in Savonlinna, Finland
Kressin et al 200927Not randomizedYesYesYesNoNoYesYesNoYesNoYesNIH/NIDCR and VAFairFair
 Pediatric clinicians can help reduce rates of early childhood caries: effects of a practice-based intervention
Lawrence et al 200828YesUnclearYesYesYesNoNoYesNo/NoYesNoYesThe Institute of Aboriginal Peoples’ Health of the Canadian Institutes of Health Research (Grant # MOP-64215) and the Toronto Hospital for Sick Children Foundation (Grant # XG 03-067)Limited: Aboriginal communities in rural CanadaGood
 A 2-y community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children
Oscarson et al 200629NRNRYesYesYesNoNoYesNoYesNoYesGrants from Count of Vasterbotten, the Patient Revenue Fund for Dental Prophylaxis and the Swedish Dental SocietyFairFair
 Influence of a low xylitol-dose on mutans streptococci colonization and caries development in preschool children
Seki et al 201130NoNoUnclear (dfs index)YesYesNoNoYesYesYesYesYesThe Uemura Fund, Nihon University School of Dentistry, a grant to promote multidisciplinary research projects from the Ministry of Education, Science, Sports, Culture and Technology, JapanFairPoor
 Effect of xylitol gum on the level of oral mutans streptococci of preschoolers: block-randomized trial
Slade et al 201131YesYesYes; some difference in fluoridation statusYesNoNoNoYesNo/NoYesNoYesProject grant #320858 from the Australian National Health and Medical Research CouncilLimited: Aboriginal communities in rural AustraliaGood
 Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial
Weinstein et al 200132YesUnclearUnclearYesUnclearUnclearUnclearYesYes/YesYesNoYesGrant No. R03 DE-012138 from NIDCR/NIHHead Start programFair
 Equivalence between massive versus standard fluoride varnish treatments in high caries children aged 3-5 y
Weinstein et al 200933YesUnclearNo; mean dmfs were not balancedYesYesUnclearUnclearYesNo/NoYesNoYesGrants No. R01DE14403 and U54DE14254 from NIDCR, NIHHead Start programFair
 Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition
Weintraub et al 200634YesYesYes; stated no imbalances apparentYesYesNoYesYesYes/NoYesNoYesUSPHS Research Grants P60 DE13058 and U54 DE142501 from the NIDCR and the NCMHD, NIH, and by the UCSF Department of Preventive and Restorative Dental SciencesLimited: “Underserviced” community in United States; all nonwhiteFair
 Fluoride varnish efficacy in preventing early childhood caries
Zhan et al 201235YesUnclearYesYesYesYesYesYesNo/Yes (23% in 1 group)YesNoYesCalifornia Society of Pediatric Dentistry Foundation, a Graduate Scientific Research Award from American Academy of Pediatric Dentistry, and NIH/NIDCR grant U54 DEO19285Single CenterFair
 Effects of xylitol wipes on carcinogenic bacteria and caries in young children
  • dfs, decayed filled surfaces; NCMHD, National Center on Minority Health and Health Disparities; NIDCR, National Institute of Dental and Craniofacial Research; NIH, National Institutes of Health; UCSF, University of California San Francisco; USPHS, United States Public Health Service; VA, Veterans Affairs; NR, not reported.