Arrest of Interproximal Caries Lesion With 38% Silver Dia... | NCT05791669

Studies
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

NCT05791669

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Status

Completed

Last Update Posted

Mar 30, 2023Actual

Enrollment

45Actual

Phase

Phase 3

Conditions

Caries Arrested

Interventions

Silver diamine fluoride
Sodium fluoride varnish

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Aug 2, 2022Actual

Completion Date

Nov 8, 2022Actual

First Submitted Date

Nov 12, 2022

First Submission Date that Met QC Criteria

Mar 17, 2023

First Posted Date

Mar 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2023

Last Update Posted Date

Mar 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.

Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
38% silver diamine fluoride	Experimental		Drug: Silver diamine fluoride
5% sodium fluoride varnish	Active Comparator		Drug: Sodium fluoride varnish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silver diamine fluoride	Drug	Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Caries arrest	Assessment with bitewing radiographs based on ICCMS radiographic scoring system	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 5 to 9 years.
Presence of at least 2 primary molars with interproximal caries.
Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).

Exclusion Criteria:

1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).

3. Children or adolescents that refuse to participate in the study or present negative behaviours.

4. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Post graduate institute of dental sciences		Rohtak	Haryana	124001	India

Intervention Browse Module

MeSH Terms

ID	Term
C024633	silver diamine fluoride
C094502	Bifluorid 12

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided