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

• ClinicalTrials.gov Identifier: NCT03568474
• Recruitment Status: Unknown
• First Posted: June 26, 2018
• Last Update Posted: June 26, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Rehan Anwar Ibrahim, Cairo University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Deep Caries	Drug: Silver Diamine Fluoride; Drug: Glass Ionomer	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel two arm groups with 1:1 allocation ratio
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: The participant, care provider, outcomes assessor and statistician will be masked
• Primary Purpose: Treatment
• Official Title: Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.
• Estimated Study Start Date: October 2018
• Estimated Primary Completion Date: October 2019
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Silver Diamine Fluoride; 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; Indirect pulp capping material; Other Name: SDF; Drug: Glass Ionomer; Indirect pulp capping material; Other Name: GI
Active Comparator: Glass Ionomer; Glass ionomer will be applied after minimal caries removal followed by composite resin restoration.	Drug: Glass Ionomer; Indirect pulp capping material; Other Name: GI

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Rehan Anwar, MSc; +201210339553; rehananwar28@hotmail.com

Contact: Sara A Mahmoud, PhD; +201000042564; sara_yn79@yahoo.com

Sponsors and Collaborators

Cairo University

Investigators

• Study Chair: Nevine G Waly, Professor; Pediatric Dentistry, Faculty of Dentistry, Cairo University
• Study Director: 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
• Principal Investigator: Rehan A Ibrahim, MSc; Pediatric Dentistry, Faculty of Dentistry, Cairo University

More Information

• Responsible Party: Rehan Anwar Ibrahim, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT03568474
• Other Study ID Numbers: Egypt Cairo University
• First Posted: June 26, 2018
• Last Update Posted: June 26, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: thesis and article publication
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: after cessation of the study
• Access Criteria: Internet

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs