Regenerative Endodontics for Non-vital Primary Molars

NCT05098483 | Completed

• 1 other identifier: Ain-Shams-University
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulp and Periapical Tissue Disease

Keywords

Regenerative endodontic treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Conventional root canal treatment

ACTIVE COMPARATOR

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

Regenerative endodontic treatment using MTA

EXPERIMENTAL

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 treatment using Biodentine

EXPERIMENTAL

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

Interventions

Regeneration in primary molars by using MTA PROCEDURE

Regenerative endodontic procedure in nonvital primary molars using MTA capping material

Regenerative endodontic treatment using MTA

Regeneration in primary molars by using biodentine PROCEDURE

Regenerative endodontic treatment in primary molars with biodentine as capping material

Regenerative endodontic treatment using Biodentine

Conventional Root canal treatment in primary molars PROCEDURE

Removal of pulp tissue from the canals of primary molars

Conventional root canal treatment

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Non-vital mandibular primary second molar.
• Restorable tooth

You may not qualify if:

• Patients allergic to medicaments or antibiotics necessary to complete the procedure.
• Special Health Care Needs
• Excessive mobility
• Presence of internal or external root resorption.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Mai Mahmoud Hasaballah

Giza, 11865, Egypt

Location

MeSH Terms

Interventions

Regeneration

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Mai Hasaballah

  AinShams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 28, 2021
• Study Start: September 5, 2023
• Primary Completion: October 26, 2024
• Study Completion: October 26, 2024
• Last Updated: July 1, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)