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

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.

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

Study Overview

• Status: Unknown
• Conditions: Deep Caries
• Intervention / Treatment: Drug: Silver Diamine Fluoride; Drug: Glass Ionomer

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: SDF; Drug: Glass Ionomer; Indirect pulp capping material; Other Names: 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 Names: GI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 23, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: Egypt Cairo University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: thesis and article publication
• IPD Sharing Time Frame: after cessation of the study
• IPD Sharing Access Criteria: Internet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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