Regenerative Endodontics for Non-vital Primary Molars

NCT ID: NCT05098483

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-10-26

Brief Summary

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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

Detailed Description

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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

Conditions

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Pulp and Periapical Tissue Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conventional Root canal treatment in primary molars

Intervention Type PROCEDURE

Removal of pulp tissue from the canals of primary molars

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

Group Type EXPERIMENTAL

Regeneration in primary molars by using MTA

Intervention Type PROCEDURE

Regenerative endodontic procedure in nonvital primary molars using MTA capping material

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

Group Type EXPERIMENTAL

Regeneration in primary molars by using biodentine

Intervention Type PROCEDURE

Regenerative endodontic treatment in primary molars with biodentine as capping material

Interventions

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Regeneration in primary molars by using MTA

Regenerative endodontic procedure in nonvital primary molars using MTA capping material

Intervention Type PROCEDURE

Regeneration in primary molars by using biodentine

Regenerative endodontic treatment in primary molars with biodentine as capping material

Intervention Type PROCEDURE

Conventional Root canal treatment in primary molars

Removal of pulp tissue from the canals of primary molars

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mai Hasaballah

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai Hasaballah

Role: PRINCIPAL_INVESTIGATOR

AinShams University

Locations

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Mai Mahmoud Hasaballah

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ain-Shams-University

Identifier Type: -

Identifier Source: org_study_id

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