Appendix quality Ratings of Randomized, Controlled Trials



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Appendix B4. Quality Ratings of Randomized, Controlled Trials


Author, Year, Title

Randomization 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 Contamination

Alamoudi et al., 201274
Effects of xylitol on salivary mutans streptococcus, plaque level, and caries activity in a group of Saudi mother-child pairs

Unclear

Yes

Unclear

Yes

Unclear

No

No

Yes

Chu et al., 200269
Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin carries in Chinese pre-school children

No

No

Unclear

Yes

Yes

No

Unclear

Yes

Davies et al., 200744 Challenges associated with the evaluation of a dental health promotion programme in a deprived urban area

Davies et al., 200543
A staged intervention dental health promotion programme to reduce early childhood caries


Not randomized

Unclear

Yes

Yes

Unclear

Unclear

Unclear

No

Du et al., 200654
A two-year randomized clinical trial of chlorhexidine varnish on dental caries in Chinese preschool children

Unclear

Unclear

Unclear

Yes

Yes

Yes

Yes

Yes

Jiang et al., 200570
The effect of a bi-annual professional application of APF foam on dental caries increment in primary teeth: 24-month clinical trial

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Kovari et al., 200351
Use of xylitol chewing gum in daycare centers: a follow-up study in Savonlinna, Finland

NR

NR

Unclear

Yes

Unclear

No

No

Yes

Kressin et al., 200945
Pediatric clinicians can help reduce rates of early childhood caries: Effects of a practice based intervention

Not randomized

Yes

Yes

Yes

No

No

Yes

Yes

Lawrence et al., 200847
A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children

Yes

Unclear

Yes

Yes

Yes

No

No

Yes

Milgrom et al., 200973
Xylitol pediatric topical oral syrup to prevent dental caries

Yes

Unclear

No (age)

Yes

Yes

Yes

Yes

Yes

Oscarson et al., 200652
Influence of a low xylitol-dose on mutans streptococci colonisation and caries development in preschool children

NR

NR

Yes

Yes

Yes

No

No

Yes

Seki et al., 201153
Effect of xylitol gum on the level of oral mutans streptococci of preschoolers: block-randomized trial

No

No

Unclear

(dfs index)



Yes

Yes

No

No

Yes

Slade et al., 201148
Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial

Yes

Yes

Yes; some difference in fluoridation status


Yes

No

No

No

Yes

Weinstein et al., 200171
Equivalence between massive versus standard fluoride varnish treatments in high caries children aged 3-5 years

Yes

Unclear

Unclear

Yes

Unclear

Unclear

Unclear

Yes

Weinstein et al., 200972
Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition

Yes

Unclear

No; mean dmfs were not balanced

Yes

Yes

Unclear

Unclear

Yes

Weintraub et al., 200649
Fluoride varnish efficacy in preventing early childhood caries

Yes

Yes

Yes; stated no imbalances apparent

Yes

Yes

No

Yes

Yes

Zhan et al., 201250
Effects of xylitol wipes on carcinogenic bacteria and caries in young children

Yes

Unclear

Yes

Yes

Yes

Yes

Yes

Yes




Author, Year, Title

Loss to Followup: Differential/High

Intention-To-Treat (ITT) Analysis

Post-Randomization Exclusions

Outcomes
Pre-Specified


Funding Source

External Validity

Quality Rating

Alamoudi et al., 201274
Effects of xylitol on salivary mutans streptococcus, plaque level, and caries activity in a group of Saudi mother-child pairs

Yes (very high)

Yes

Yes

Yes

The Deanship of Scientific Research, King Abdulaziz University, Jeddah, Saudi Arabia (Project No. 429/011-9)

Fair

Poor

Chu et al., 200269
Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin carries in Chinese pre-school children

No//No

Yes

No

Yes

A research grant from The University of Hong Kong (CRCG)

Limited: Chinese fluoridated water, 73% used fluoridated toothpaste

Poor

Davies et al., 200744 Challenges associated with the evaluation of a dental health promotion programme in a deprived urban area

Davies et al., 200543
A staged intervention dental health promotion programme to reduce early childhood caries


Yes

No

No

Yes

National Health Service Research and Development Programme for Primary Dental Care

Fair

Poor

Du et al., 200654
A two-year randomized clinical trial of chlorhexidine varnish on dental caries in Chinese preschool children

No/Unclear

Yes

No

Yes

The National Key Technologies R & D Program of the tenth Five-Year Plan, the Ministry of Science and Technology, and the National Committee for Oral Health, China

Limited: Chinese children in China, no organized oral health care programs, but access to fluoridated water

Fair

Jiang et al., 200570
The effect of a bi-annual professional application of APF foam on dental caries increment in primary teeth: 24-month clinical trial


No/No

Yes

No

Yes

National Key Technologies

R & D Program of the Tenth-five Year Plan, the Ministry of Science and Technology, China (2004BA720A24)



Limited: Chinese children, fluoridated water, no organized health care programs, limited use of fluoride toothpaste

Good

Kovari et al., 200351
Use of xylitol chewing gum in daycare centers: a follow-up study in Savonlinna, Finland

No

Yes

No

Yes

NR

Limited

Fair

Kressin et al., 200945
Pediatric clinicians can help reduce rates of early childhood caries: Effects of a practice based intervention

No

Yes

No

Yes

NIDCR, NIH, and VA

Fair

Fair

Lawrence et al., 200847
A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children

No/No

Yes

No

Yes

The 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 Canada

Good

Milgrom et al., 200973
Xylitol pediatric topical oral syrup to prevent dental caries

No

Yes

No

Yes

The Maternal and Child Health Bureau (HRSA) and NIDCR

Fair

Fair

Oscarson et al., 200652
Influence of a low xylitol-dose on mutans streptococci colonisation and caries development in preschool children

No

Yes

No

Yes

Grants from Count of Vasterbotten, the Patient Revenue Fund for Dental Prophylaxis and the Swedish Dental Society

Fair

Fair

Seki et al., 201153
Effect of xylitol gum on the level of oral mutans streptococci of preschoolers: block-randomized trial

Yes

Yes

Yes

Yes

The Uemura Fund, Nihon University School of Dentistry

Fair

Poor

Slade et al., 201148
Effect of health promotion and fluoride varnish on dental caries among Australian Aboriginal children: results from a community-randomized controlled trial

No/No

Yes

No

Yes

Project grant 320858 from the Australian National Health and Medical Research Council

Limited: Aboriginal communities in rural Australia

Good

Weinstein et al., 200171
Equivalence between massive versus standard fluoride varnish treatments in high caries children aged 3-5 years

Yes/Yes

Yes

No

Yes

Grant R03 DE012138 from NIDCR, NIH

Head Start program

Fair

Weinstein et al., 200972
Randomized equivalence trial of intensive and semiannual applications of fluoride varnish in the primary dentition

No/No

Yes

No

Yes

Grants R01DE14403 and U54DE14254 from NIDCR, NIH

Head Start program

Fair

Weintraub et al., 200649
Fluoride varnish efficacy in preventing early childhood caries

Yes/No

Yes

No

Yes

USPHS research grants P60DE13058 and U54DE142501 from NIDCR and NCMHD, NIH; and by UCSF’s Department of Preventive and Restorative Dental Sciences

Limited: "Under- serviced" community in U.S.; all non-white

Fair

Zhan et al., 201250
Effects of xylitol wipes on carcinogenic bacteria and caries in young children

No/Yes

23% in one group



Yes

No

Yes

California Society of Pediatric Dentistry Foundation (a Graduate Scientific Research Award from AAPD) and NIH/NIDCR grant U54 DEO19285

Single center

Fair


Abbreviations: AAPD = American Academy of Pediatric Dentistry; dfs = decayed filled surfaces; dmfs = decayed missing filled surfaces; HRSA = Health Resources and Services Administration; NCMHD = National Center on Minority Health and Health Disparities; NIDCR = National Institute of Dental and Craniofacial Research; NIH = National Institutes of Health; NR = not reported; UCSF = University of California San Francisco; U.S. = United States; USPHS = U.S. Public Health Service; VA = U.S. Department of Veterans Affairs.

Prevention of Dental Caries in Children Pacific Northwest Evidence-based Practice Center



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