Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial

Aim of the study:

To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Caries
• Intervention / Treatment: Drug: Silver diamine fluoride; Drug: Mineral trioxide aggregate

Detailed Description

Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.

Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa Ahmed Ahmed Zaghloul; Phone Number: +201002798304; Email: marwa_zaghloul@dentistry.cu.edu.eg
• Study Contact Backup: Name: Randa Youssef Abd Al Gawad; Email: randa.youssef@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient and parent showing cooperation and compliance.
• Children 9-14 years old
• Vital deeply carious young first permanent molar(s) with complete root formation
• Asymptomatic teeth or without clinical symptoms of spontaneous pain
• Both genders will be included.

Exclusion Criteria:

• Children unable to return for recall visits.
• Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).
• Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silver diamine fluoride group; partial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling	Drug: Silver diamine fluoride; First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.; Other Names: SDF
Active Comparator: mineral trioxide aggregate group; partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling	Drug: Mineral trioxide aggregate; First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.; Other Names: MTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin bridge formation	Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)	1 week
Absence of sinus or fistula	Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)	3 months
Absence of sinus or fistula	Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)	6 months
radiographic success	Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones will be assessed if present or absent by digital radiographic examination, Binary (present or absent)	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Manal Ahmed El Sayed, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University; Principal Investigator: Randa Youssef Abd Al Gawad, Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: indirect pulp capping; partial caries removal; fluorides
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: Indirect pulp capping

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No