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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05425368
Other study ID # Indirect pulp capping
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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