Medical Management of Caries in the Primary Dentition Using Silver Nitrate

Early Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Procedure: Prophylaxis; Drug: Fluoride varnish; Drug: Silver Nitrate

• Registration Number: NCT02604134
• Lead Sponsor: Arwa Owais

Brief Summary

This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.

Detailed Description

This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.

Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Primary Completion: 2017-08-24
• Study Completion: 2018-08-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
• Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study

Exclusion Criteria

• Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
• Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
• Known allergy/sensitivity to any of the dental materials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment group	Prophylaxis	The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
Silver Nitrate group	Prophylaxis	The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
Silver Nitrate group	Fluoride varnish	The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
conventional treatment group	Fluoride varnish	The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
Silver Nitrate group	Silver Nitrate	The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.

Primary Outcome Measures

Name	Time	Method
Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)	through study completion, for 2 years	Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4

Secondary Outcome Measures

Name	Time	Method
Caries activity in primary teeth	through study completion, for 2 years	Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores.

Trial Locations

Locations (1)

UIowa; 🇺🇸 Iowa City, Iowa, United States