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

NCT ID: NCT03568474

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Deep Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel two arm groups with 1:1 allocation ratio
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The participant, care provider, outcomes assessor and statistician will be masked

Study Groups

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Silver Diamine Fluoride

Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration.

Group Type EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type DRUG

Indirect pulp capping material

Glass Ionomer

Intervention Type DRUG

Indirect pulp capping material

Glass Ionomer

Glass ionomer will be applied after minimal caries removal followed by composite resin restoration.

Group Type ACTIVE_COMPARATOR

Glass Ionomer

Intervention Type DRUG

Indirect pulp capping material

Interventions

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Silver Diamine Fluoride

Indirect pulp capping material

Intervention Type DRUG

Glass Ionomer

Indirect pulp capping material

Intervention Type DRUG

Other Intervention Names

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SDF GI

Eligibility Criteria

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Inclusion Criteria

1. Patients free from any systematic diseases.
2. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
4. The absence of clinical symptoms of irreversible pulpitis.
5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
6. Compliant patient/ parent.

Exclusion Criteria

1. Teeth with previous restorative treatment.
2. Unrestorable teeth.
3. Uncooperative patients.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rehan Anwar Ibrahim

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nevine G Waly, Professor

Role: STUDY_CHAIR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Sara A Mahmoud, PhD

Role: STUDY_DIRECTOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Mohamed K Zayt, PhD

Role: STUDY_DIRECTOR

Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University

Rehan A Ibrahim, MSc

Role: PRINCIPAL_INVESTIGATOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Central Contacts

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Rehan Anwar, MSc

Role: CONTACT

+201210339553

Sara A Mahmoud, PhD

Role: CONTACT

+201000042564

Other Identifiers

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Egypt Cairo University

Identifier Type: -

Identifier Source: org_study_id

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