Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Not Applicable

• Conditions: Deep Caries
• Interventions: Drug: Silver diamine fluoride; Drug: Mineral trioxide aggregate

• Registration Number: NCT05425368
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-15
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Study Start: 2022-08-01
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver diamine fluoride group	Silver diamine fluoride	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
mineral trioxide aggregate group	Mineral trioxide aggregate	partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling

Primary Outcome Measures

Name	Time	Method
Dentin bridge formation	6 months	Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	1 week	Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)
Absence of sinus or fistula	6 months	Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)
radiographic success	6 months	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)