Comparative Effectiveness of Treatments to Prevent Dental Caries

Status Completed

Clinical Trial Summary

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New Hampshire.

Clinical Trial Description

Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries. This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income children enrolled in public elementary schools in New Hampshire from 2017-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Caries arrest will be evaluated after two years, and caries prevention will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05. Notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children. ;

Study Design

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT03448107
Study type	Interventional
Source	NYU College of Dentistry
Contact
Status	Completed
Phase	N/A
Start date	September 20, 2017
Completion date	June 30, 2023

View Details

See also
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
Completed	`NCT02019563` - MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial	Phase 2