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Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials

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

Status
Enrolling by invitation
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06976411
Enrollment
30
Registered
2025-05-16
Start date
2022-12-01
Completion date
2025-12-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Root Perforation at the Bifurcation Area

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.

Interventions

DRUGMTA

Perforation repair using MTA repair material

DRUGBioceramic putty

Perforation repair using Bioceramic repair material

Sponsors

Ain Shams University
CollaboratorOTHER
Mohamed Salah Elwakeel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic success in terms of healing1 yearHealing 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 success1 yearA successful clinical outcome was defined as follows: no indication of apical periodontitis, no clinical signs and symptoms, and no loss of function.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026