Regenerative Endodontics for Non-vital Primary Molars

Pulp and Periapical Tissue Disease Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05098483
• Other study ID #: Ain-Shams-University
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: December 26, 2025

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

Description:

Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:

Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 26, 2025
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Non-vital mandibular primary second molar.

• Restorable tooth

Exclusion Criteria:

• Patients allergic to medicaments or antibiotics necessary to complete the procedure.

• Special Health Care Needs

• Excessive mobility

• Presence of internal or external root resorption.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Periapical Diseases
• Pulp and Periapical Tissue Disease

Intervention

Procedure:
• Regeneration in primary molars by using MTA
Regenerative endodontic procedure in nonvital primary molars using MTA capping material
• Regeneration in primary molars by using biodentine
Regenerative endodontic treatment in primary molars with biodentine as capping material
• Conventional Root canal treatment in primary molars
Removal of pulp tissue from the canals of primary molars

Locations

Country	Name	City	State
Egypt	Mai Mahmoud Hasaballah	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical measures	42 children with no pain or swelling (i.e) successful outcomes	12 months
Primary	Radiographic measures	42 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome	12 months