Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

NCT06976411 | Enrolling By Invitation Phase 4

• 1 other identifier: FDASU-REC 1117 pro
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Root Perforation at the Bifurcation Area

Outcome Measures

Primary Outcomes (2)

• Radiographic success in terms of healing

  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"

  1 year

• patients with clinical success

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

  1 year

Study Arms (2)

MTA

EXPERIMENTAL

Drug: MTA

Bioceramic

EXPERIMENTAL

Drug: Bioceramic putty

Interventions

MTA DRUG

Perforation repair using MTA repair material

MTA

Bioceramic putty DRUG

Perforation repair using Bioceramic repair material

Bioceramic

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Salah Elwakeel: lead
• Ain Shams University: collaborator

Study Sites (1)

Faculty of dentistry ain shams university

Cairo, Egypt

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2024-12

Locations

EG (1)