Effect of Two Irrigation Protocols Applied Prior to Furcation Repair

NCT06757660 | Completed DMC

• 1 other identifier: Shreef Mostafa
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Perforations are mishaps that might occur during the course of endodontic treatment mainly due to iatrogenic factors. However, they might also occur due to extensive decay of dentinal structure. A perforation creates a pathological passage between the root canal system and the periodontium and jeopardizes the success of the endodontic therapy. The damage caused by the perforation may eventually result in the extraction of the compromised tooth

Conditions

Furcation Defects

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Post-operative pain will be measured by a numerical pain rating scale (NRS), where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

  From 1 day to 7 days after The Procedure

Secondary Outcomes (1)

• Healing

  From base line to 3,6 and 9 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

About 20 patients will be irrigated with Sodium hypochlorite (NaOCL 2.5%).using a negative pressure irrigation system to minimizes the risk of irrigant extrusion into the furcation space.

Procedure: Furcation Repair

Group B

ACTIVE COMPARATOR

About 20 patients will be irrigated with nanoparticle chitosan (2 %).

Procedure: Furcation Repair

Interventions

Furcation Repair PROCEDURE

to evaluate the clinical and radiographic effects of chitosan and Naocl as an irrigation protocols applied during repair of furcation perforation.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with old furcation perforation of mandibular molar.
• Size of perforation should be of average 1 to 2 mm.
• Period till treatment should be done within one month.
• Presence of polyp at the site of perforation is required in this study.

You may not qualify if:

• Teeth in need for post retained restoration.
• Immunocompromised patients.
• Pregnant women and smokers.
• Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University, Faculty of Dentistry

Minya, Egypt

Location

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dalia Ali Moukarab, Professor

  Endodontics,Faculty of Dentistry, Minia University

  STUDY CHAIR

• Esam Fawzy, Lecturer

  Department of Endodontics, Faculty of Dentistry Minia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Endodontics at Deraya University, minia

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: October 10, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 20, 2024
• Last Updated: February 2, 2026

Record last verified: 2023-10

Locations

EG (1)