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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)

NCT05943769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-07-13

No results posted yet for this study

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.

Conditions

  • Periapical Diseases
  • Periapical Cyst

Interventions

PROCEDURE

Apical microsurgery

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-08-20
Completion
2022-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943769 on ClinicalTrials.gov