Effect of Two Irrigation Protocols Applied Prior to Furcation Repair

NCT ID: NCT06757660

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-07-20

Brief Summary

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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

Detailed Description

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Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible and has chelating abilities, making it an interesting alternative to modern root canal irrigants.

Inadequacy of the repair materials has been a contributing factor to the poor outcome of repair procedures. On the basis of the recent physical and biologic property studies of the relatively new introduced mineral trioxide aggregate, this material may be suitable for closing the communication between the pulp chamber and the underlying periodontal tissues. There are few reports on repair of furcal perforation with MTA in molar teeth.

Several studies have stated the ability of chitosan as a chelating agent that potentially enhance the dentin wettability. At the same time, chitosan nanoparticles showed the potential to stabilize dentine collagen by providing resistance to bacterial collagenase degradation.

The null hypothesis: there is no difference in pain and healing between the two irrigation protocols of old fural perforations prior to application of Bio C repair material.

Conditions

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Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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.

Group Type ACTIVE_COMPARATOR

Furcation Repair

Intervention Type PROCEDURE

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

Group B

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

Group Type ACTIVE_COMPARATOR

Furcation Repair

Intervention Type PROCEDURE

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

Interventions

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Furcation Repair

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Shreef Mostafa Ibrahim

Assistant lecturer of Endodontics at Deraya University, minia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia Ali Moukarab, Professor

Role: STUDY_CHAIR

Endodontics,Faculty of Dentistry, Minia University

Esam Fawzy, Lecturer

Role: STUDY_DIRECTOR

Department of Endodontics, Faculty of Dentistry Minia University

Locations

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Minia University, Faculty of Dentistry

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Shreef Mostafa

Identifier Type: -

Identifier Source: org_study_id

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