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

NCT03568474 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Egypt Cairo University
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)

  9 months

Secondary Outcomes (4)

• Tooth vitality

  9 months

• Abscess

  9 months

• Pain on percussion

  9 months

• Root lengthening

  9 months

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

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

Drug: Silver Diamine Fluoride; Drug: Glass Ionomer

Glass Ionomer

ACTIVE COMPARATOR

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

Drug: Glass Ionomer

Interventions

Silver Diamine Fluoride DRUG

Indirect pulp capping material

Also known as: SDF

Silver Diamine Fluoride

Glass Ionomer DRUG

Indirect pulp capping material

Also known as: GI

Glass Ionomer; Silver Diamine Fluoride

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients free from any systematic diseases.
• 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.
• Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
• The absence of clinical symptoms of irreversible pulpitis.
• Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
• Compliant patient/ parent.

You may not qualify if:

• Teeth with previous restorative treatment.
• Unrestorable teeth.
• Uncooperative patients.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

silver diamine fluoride; glass ionomer

Study Officials

• Nevine G Waly, Professor

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY CHAIR

• Sara A Mahmoud, PhD

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Mohamed K Zayt, PhD

  Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Rehan A Ibrahim, MSc

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehan Anwar, MSc

CONTACT

+201210339553; rehananwar28@hotmail.com

Sara A Mahmoud, PhD

CONTACT

+201000042564; sara_yn79@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant, care provider, outcomes assessor and statistician will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: parallel two arm groups with 1:1 allocation ratio

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 26, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: April 1, 2020
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after cessation of the study
• Access Criteria: Internet