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Enrolling by Invitation

NCT Number: NCT06976411

Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.

The main questions it aims to answer are:

is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?

Participants will:

enrollment will be from out-patients clinic of endodontic department, faculty of dentistry, Ain Shams university with root perforations. perforation repair will be done using either bio-ceramic or MTA repair material and preoperative or immediate postoperative CBCT and postoperative CBCT will be taken to compare healing.

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Key information

Conditions

Root Perforation at the Bifurcation Area

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry ain shams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with root perforation in lower molars.
  • Patients had anon contributory medical history.
  • Patients of age categories between 15 to 50 years old.
  • No sex restriction.
  • Small to medium size perforation.

Exclusion criteria

  • Patients with generalized chronic periodontitis.
  • Teeth with difficult isolation.
  • Non restorable teeth.
  • Medically compromised patients.
  • Patients with history of allergies to any of the medications to be used during or after the treatment.

Treatment and study plan

MTA

Drug

Perforation repair using MTA repair material

Bioceramic putty

Drug

Perforation repair using Bioceramic repair material

Primary outcomes

  1. Radiographic success in terms of healing

    Time frame: 1 year

    Healing outcome: the presence or absence of lesion and its size were obtained by analyzing CBCT of each case and classified into: Cases with complete resolution of lesion considered as "Healed", reduction of size considered as "Healing", and no size change or increase in lesion size considered as "Failure"

  2. patients with clinical success

    Time frame: 1 year

    A successful clinical outcome was defined as follows: no indication of apical periodontitis, no clinical signs and symptoms, and no loss of function.

Sponsors and collaborators

Lead sponsor

Mohamed Salah Elwakeel

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

Prospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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