Regenerative Endodontics for Non-vital Primary Molars

Not Applicable

Active, not recruiting

• Conditions: Pulp and Periapical Tissue Disease
• Interventions: Procedure: Regeneration in primary molars by using MTA; Procedure: Regeneration in primary molars by using biodentine; Procedure: Conventional Root canal treatment in primary molars

• Registration Number: NCT05098483
• Lead Sponsor: Ain Shams University

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

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 Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-10-28
• Study Start: 2022-10-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-04-26
• Study Completion: 2025-05-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regenerative endodontic treatment using MTA	Regeneration in primary molars by 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
Regenerative endodontic treatment using Biodentine	Regeneration in primary molars by 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
Conventional root canal treatment	Conventional Root canal treatment in primary molars	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mai Mahmoud Hasaballah; 🇪🇬 Giza, Egypt