Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars

NCT04777968 | Completed Phase 4

• 1 other identifier: 19739
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental caries. In order to avoid serious complications of untreated dental caries such as pain, infections, emergency visits and possibly hospitalization , an effective low cost treatment should be identified particularly in areas with poor dental access. Studies have proven that silver diamine fluoride (SDF) is a topical fluoride that has the ability to effectively arrest and prevent dental caries.

Conditions

Dental Caries

Keywords

Silver Diamine Fluoride; Resin Modified Glass Ionomer; Fluoride Uptake; Carious primary teeth

Outcome Measures

Primary Outcomes (1)

• Fluoride uptake into dentine

  Fluoride weight percent in dentin under Resin Modified Glass Ionomer Restoration in primary molars

  2 weeks

Study Arms (2)

Control Group (A) : RMGI restoration without SDF and KI.

NO INTERVENTION

• RMGI restoration without SDF and KI.

Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration.

EXPERIMENTAL

• Pretreatment with SDF and KI prior to RMGI restoration.

Drug: Silver diamine fluoride

Interventions

Silver diamine fluoride DRUG

a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.

Also known as: SDF and KI

Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Carious primary extracted molars.
• Presence of occlusal or proximal caries.
• Caries extending to dentine.

You may not qualify if:

• Presence of restorations.
• Presence of pit and fissure sealant.
• Hypolpastic teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, 0022, Egypt

Location

Faculty of Dentistry, Cairo University

Cairo, 0022, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rania Nasr, Assoc. Prof.

  Faculty of Dentistry, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principle investigator \& co-investigator are masked before assessing the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr. Rania Nasr

Model Details: Extracted Discarded Primary Molars divided into CONTROL Group \& INTERVENTIONAL Group

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)