Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries

Phase 4

• Conditions: Deep Caries
• Interventions: Drug: Silver Diamine Fluoride; Drug: Glass Ionomer

• Registration Number: NCT03568474
• Lead Sponsor: Cairo University

Brief Summary

This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

Detailed Description

The study will be carried on young permanent molars with open apices \& with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-14
• Last Update Submitted: 2018-06-23
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Study Start: 2018-10
• Primary Completion: 2019-10
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver Diamine Fluoride	Glass Ionomer	Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration.
Glass Ionomer	Glass Ionomer	Glass ionomer will be applied after minimal caries removal followed by composite resin restoration.
Silver Diamine Fluoride	Silver Diamine Fluoride	Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	9 months	Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)

Secondary Outcome Measures

Name	Time	Method
Pain on percussion	9 months	Will be assessed by Percussion test by using the back of the mirror on the tooth, binary (yes or no)
Tooth vitality	9 months	Will be assessed by Vitality test using thermal stimulation, binary (yes or no)
Root lengthening	9 months	Will be assessed measuring the root length by mm on the digital radiography (digora software)
Abscess	9 months	Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no)