Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

Phase 4

• Conditions: Root Perforation at the Bifurcation Area
• Interventions: Drug: MTA; Drug: Bioceramic putty

• Registration Number: NCT06976411
• Lead Sponsor: Mohamed Salah Elwakeel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2024-12
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTA	MTA	-
Bioceramic	Bioceramic putty	-

Primary Outcome Measures

Name	Time	Method
Radiographic success in terms of healing	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"
patients with clinical success	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.

Trial Locations

Locations (1)

Faculty of dentistry ain shams university; 🇪🇬 Cairo, Egypt