Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Deep Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05425368
• Other study ID #: Indirect pulp capping
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: Cairo University
• Contact: Marwa Ahmed Ahmed Zaghloul
• Phone: +201002798304
• Email: marwa_zaghloul[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deep Caries

Intervention

Drug:
• Silver diamine fluoride
First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.
• Mineral trioxide aggregate
First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentin bridge formation	Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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