Regenerative Endodontics for Non-vital Primary Molars

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)

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

Study Overview

• Status: Completed
• Conditions: Pulp and Periapical Tissue Disease
• Intervention / Treatment: Procedure: Conventional Root canal treatment in primary molars; Procedure: Regeneration in primary molars by using MTA; Procedure: Regeneration in primary molars by using biodentine

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11865
    • Mai Mahmoud Hasaballah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional root canal treatment; The caries will be removed. An excavator will be used to remove the coronal portion of the dental pulp while the radicular portion will be cleaned using k- files. 2.5% Sodium hypochlorite will be used as irrigant solution.The canals will be filled with ZOE cement and a stainless-steel crown will be inserted to restore the tooth.	Procedure: Conventional Root canal treatment in primary molars; Removal of pulp tissue from the canals of primary molars
Experimental: Regenerative endodontic treatment using MTA; Access cavity will be prepared in each primary molar then each canal will be copiously irrigated by sodium hypochlorite. Triple antibiotic paste will be inserted in eash canal then sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that induction of bleeding will be created by overinstumentation inside each canal. Finally sealed with MTA under the GIC restoration and S.S.C	Procedure: Regeneration in primary molars by using MTA; Regenerative endodontic procedure in nonvital primary molars using MTA capping material
Experimental: Regenerative endodontic treatment using Biodentine; Access cavity will be prepared in each primary molar then canals will be copiously irrigated by sodium hypochlorite. Mixture of Triple antibiotic paste will be introduced in eash canal then cavity will be sealed with temporary restoration till the second visit. In the second visit canals will be irrigated with EDTA, after that bleeding will be created by overinstumentation inside each canal. Finally sealed with biodentine under the GIC restoration and S.S.C	Procedure: Regeneration in primary molars by using biodentine; Regenerative endodontic treatment in primary molars with biodentine as capping material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical measures	39 children with no pain or swelling (i.e) successful outcomes	12 months
Radiographic measures	39 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mai Hasaballah, AinShams University

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Actual): October 26, 2024
• Study Completion (Actual): October 26, 2024

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Regenerative endodontic treatment
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Dental Pulp Diseases; Periapical Diseases
• Other Study ID Numbers: Ain-Shams-University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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