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The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)

Primary Purpose

Periapical Diseases, Periapical Cyst

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Apical microsurgery
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Diseases focused on measuring Apicoectomy, Bone graft, Endodontic surgery, MTA, TotalFill, Apical lesions

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patients must be medically free from any systemic disease that can affect bone healing. Age range of the patient should be between 20 - 45 years old. All patients must have good oral hygiene. The size of the radiolucent area is of small-moderate size (up to 3 cm in highest diameter at any axis in CBCT), related to a single rooted maxillary tooth. Periradicular disease in a root-filled tooth where orthograde root canal treatment options has failed, Exclusion Criteria: Patient with systemic disease that may affect bone healing. Patients above 45 years or patients below 20 years. Patients with very poor oral hygiene. Teeth presenting with apico-marginal defects or teeth with periodontal disease (periodontal pockets and/or mobility). Surgery after previous endodontic surgery (re-surgery cases), root resections and amputations, cases presenting with root fractures. Patients with history of allergies to any of the medications to be used during or after the surgery.

Sites / Locations

  • Ain Shams univetsity

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

MTA

TotalFill

MTA & bone

TotalFill & bone

Arm Description

Root end filling material is MTA without bone graft in the defect.

Root end filling material is TotalFill without bone graft in the defect.

Root end filling material is MTA with the addition of composite bone graft in the defect.

Root end filling material is TotalFill with the addition of composite bone graft in the defect.

Outcomes

Primary Outcome Measures

Healing
Assessing healing using CBCT

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
July 6, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05943769
Brief Title
The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
Official Title
The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
The goal of this triple blinded randomized clinical trial is to evaluate the effect of combining different bioactive root end filling materials with composite bone graft (xenogeneic mixed with autogenous bone fragments) on the healing process of periapical tissues after endodontic micro-surgery procedure on patients with small to moderate sized lesions. The main questions it aims to answer are: Will the use of Totalfill in Endodontic surgeries show comparable results to the gold standard MTA? Will the addition of composite bone graft (Xenogenic and Autogenous) affect the healing of small to moderate sized lesions? Is there any interaction between composite bone graft and different bioactive root-end filling materials? Participants were allocated to 4 different groups according to the root-end filling material used with or without bone graft. Reseachers compared between MTA only group, Totalfill only group, MTA with bone group, and Totalfill with bone group to evaluate healing of the periapical lesion using CBCT after 12 months follow up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases, Periapical Cyst
Keywords
Apicoectomy, Bone graft, Endodontic surgery, MTA, TotalFill, Apical lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTA
Arm Type
Experimental
Arm Description
Root end filling material is MTA without bone graft in the defect.
Arm Title
TotalFill
Arm Type
Experimental
Arm Description
Root end filling material is TotalFill without bone graft in the defect.
Arm Title
MTA & bone
Arm Type
Experimental
Arm Description
Root end filling material is MTA with the addition of composite bone graft in the defect.
Arm Title
TotalFill & bone
Arm Type
Experimental
Arm Description
Root end filling material is TotalFill with the addition of composite bone graft in the defect.
Intervention Type
Procedure
Intervention Name(s)
Apical microsurgery
Other Intervention Name(s)
apicoectomy
Intervention Description
inoculation of the periapical or the periradicular lesion with the sectioning of the apical 3mm of the root followed by root-end cavity preparation and retro-filling with the MTA or TotalFill with or without composite bone grafting according to patient allocation.
Primary Outcome Measure Information:
Title
Healing
Description
Assessing healing using CBCT
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients must be medically free from any systemic disease that can affect bone healing. Age range of the patient should be between 20 - 45 years old. All patients must have good oral hygiene. The size of the radiolucent area is of small-moderate size (up to 3 cm in highest diameter at any axis in CBCT), related to a single rooted maxillary tooth. Periradicular disease in a root-filled tooth where orthograde root canal treatment options has failed, Exclusion Criteria: Patient with systemic disease that may affect bone healing. Patients above 45 years or patients below 20 years. Patients with very poor oral hygiene. Teeth presenting with apico-marginal defects or teeth with periodontal disease (periodontal pockets and/or mobility). Surgery after previous endodontic surgery (re-surgery cases), root resections and amputations, cases presenting with root fractures. Patients with history of allergies to any of the medications to be used during or after the surgery.
Facility Information:
Facility Name
Ain Shams univetsity
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)

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