Regenerative Endodontics for Non-vital Primary Molars

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05098483

Collaborator

(none)

Enrollment

Location

Arms

12.7

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pulp and Periapical Tissue Disease	Procedure: Regeneration in primary molars by using MTA Procedure: Regeneration in primary molars by using biodentine Procedure: Conventional Root canal treatment in primary molars	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Oct 26, 2023

Anticipated Study Completion Date :

Dec 26, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical measures [12 months]
42 children with no pain or swelling (i.e) successful outcomes
Radiographic measures [12 months]
42 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mai Mahmoud Hasaballah	Giza		Egypt	11865

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Mai Hasaballah, AinShams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mai Hasaballah, Principal investigator, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05098483

Other Study ID Numbers:

Ain-Shams-University

First Posted:

Oct 28, 2021

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mai Hasaballah, Principal investigator, Ain Shams University

Regenerative endodontic treatment

Additional relevant MeSH terms:

Dental Pulp Diseases

Periapical Diseases

Study Results

No Results Posted as of Feb 16, 2022