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Regenerative Endodontics for Non-vital Primary Molars

Primary Purpose

Pulp and Periapical Tissue Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Regeneration in primary molars by using MTA
Regeneration in primary molars by using biodentine
Conventional Root canal treatment in primary molars
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp and Periapical Tissue Disease focused on measuring Regenerative endodontic treatment

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mai Mahmoud Hasaballah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional root canal treatment

Regenerative endodontic treatment using MTA

Regenerative endodontic treatment using Biodentine

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 17, 2021
Last Updated
January 30, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05098483
Brief Title
Regenerative Endodontics for Non-vital Primary Molars
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 5, 2023 (Anticipated)
Primary Completion Date
October 26, 2024 (Anticipated)
Study Completion Date
December 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp and Periapical Tissue Disease
Keywords
Regenerative endodontic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional root canal treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regenerative endodontic treatment using MTA
Arm Type
Experimental
Arm Description
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
Arm Title
Regenerative endodontic treatment using Biodentine
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Regeneration in primary molars by using MTA
Intervention Description
Regenerative endodontic procedure in nonvital primary molars using MTA capping material
Intervention Type
Procedure
Intervention Name(s)
Regeneration in primary molars by using biodentine
Intervention Description
Regenerative endodontic treatment in primary molars with biodentine as capping material
Intervention Type
Procedure
Intervention Name(s)
Conventional Root canal treatment in primary molars
Intervention Description
Removal of pulp tissue from the canals of primary molars
Primary Outcome Measure Information:
Title
Clinical measures
Description
42 children with no pain or swelling (i.e) successful outcomes
Time Frame
12 months
Title
Radiographic measures
Description
42 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai Hasaballah
Phone
01001449394
Email
maihasaballah@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Hasaballah
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mai Mahmoud Hasaballah
City
Giza
ZIP/Postal Code
11865
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai Hasaballah, Ass.lec
Phone
01001449394
Email
maihasaballah@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Regenerative Endodontics for Non-vital Primary Molars

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