Dental Caries Clinical Trial
Official title:
Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial
Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth. Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds. Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04127929 -
Investigation of Glass Carbomer Performance
|
N/A | |
Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Active, not recruiting |
NCT04475679 -
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
|
N/A | |
Completed |
NCT05438381 -
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
|
N/A | |
Not yet recruiting |
NCT03037814 -
Clinical Performance of Restorative Materials in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT05202665 -
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
|
N/A | |
Terminated |
NCT01147835 -
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
|
N/A | |
Not yet recruiting |
NCT04033263 -
Maintaining Oral Health With Bio-products
|
N/A | |
Enrolling by invitation |
NCT04438252 -
Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
|
N/A | |
Not yet recruiting |
NCT03609034 -
Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
|
||
Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
Completed |
NCT02473107 -
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
|
N/A | |
Active, not recruiting |
NCT02537184 -
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
|
N/A | |
Completed |
NCT01950546 -
Nanosilver Fluoride to Prevent Dental Biofilms Growth
|
Phase 1 | |
Recruiting |
NCT02734420 -
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
|
Phase 1 | |
Completed |
NCT02020681 -
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions
|
N/A | |
Completed |
NCT02234609 -
Effectiveness of Modified Class IV Atraumatic Restorative Treatment
|
N/A | |
Completed |
NCT02426619 -
Arresting Active Dental Caries in Preschool Children by Topical Fluorides
|
Phase 2/Phase 3 | |
Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A |