Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth

Status Recruiting

Clinical Trial Summary

In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. The objective of this study is to compare the effectiveness of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected kindergartens will be invited to participate in this clinical trial. Only generally healthy children with written parental consent will be included. At baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. After the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: Group A - semi-annual topical application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C - semi-annual application of placebo control with tonic water. Clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. The results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of SDF for preventing occlusal caries in primary molars. The study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether SDF should be complemented in a school-based caries prevention program.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05084001
Study type	Interventional
Source	The University of Hong Kong
Contact
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	March 1, 2020
Completion date	July 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03637309` - Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile	N/A
Completed	`NCT05531435` - Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients	N/A
Recruiting	`NCT04538963` - Arrest of Proximal Caries Using Orthodontic Bands and Glass Ionomer Cement	N/A
Not yet recruiting	`NCT05529433` - Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars	N/A
Completed	`NCT03063307` - Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries	N/A
Recruiting	`NCT05512156` - Toothbrushing Program in Saudi Arabia "TOPS"	N/A
Not yet recruiting	`NCT06081868` - RCT on Effectiveness of Oral Health Preventive Programmes in School Children in Uganda	N/A
Recruiting	`NCT06011005` - Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.	N/A
Completed	`NCT05645029` - Evaluation of Glass Ionomer Cement Modified With Chlorhexidine and Titanium Dioxide in Primary Molars (RCT)	N/A
Recruiting	`NCT04195386` - Efficacy of a Chemically Activated Composite Resin Alkasite in Atypical Caries Lesions of Deciduous Teeth	N/A
Recruiting	`NCT04195022` - Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth	N/A
Completed	`NCT03480516` - Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children	N/A
Completed	`NCT03311438` - Oral Health Intervention Program for Children With Congenital Heart Defects	N/A
Completed	`NCT05110534` - Supportive Caries Preventive Programme in Children Undergoing Dental General Anaesthesia	N/A
Completed	`NCT05638217` - Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children
Completed	`NCT02002728` - Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.	N/A
Active, not recruiting	`NCT05121584` - Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth	N/A
Completed	`NCT04666597` - Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
Completed	`NCT05652231` - Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
Completed	`NCT06018584` - Biostimulation After Tooth Extraction	N/A