NCT05943769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
Last Updated

July 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

July 6, 2023

Last Update Submit

July 6, 2023

Conditions

Periapical DiseasesPeriapical Cyst

Keywords

ApicoectomyBone graftEndodontic surgeryMTATotalFillApical lesions

Outcome Measures

Primary Outcomes (1)

  • Healing

    Assessing healing using CBCT

    12 months

Study Arms (4)

MTA

EXPERIMENTAL

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

Procedure: Apical microsurgery

TotalFill

EXPERIMENTAL

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

Procedure: Apical microsurgery

MTA & bone

EXPERIMENTAL

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

Procedure: Apical microsurgery

TotalFill & bone

EXPERIMENTAL

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

Procedure: Apical microsurgery

Interventions

Apical microsurgeryPROCEDURE

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.

Also known as: apicoectomy
MTAMTA & boneTotalFillTotalFill & bone

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams univetsity

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Periapical DiseasesRadicular Cyst

Interventions

Apicoectomy

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontal CystOdontogenic CystsJaw CystsBone CystsCystsNeoplasmsMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeEndodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 13, 2023

Study Start

January 1, 2020

Primary Completion

August 20, 2021

Study Completion

October 30, 2022

Last Updated

July 13, 2023

Record last verified: 2023-06

Locations

EG(1)