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CompletedNCT06757660Updated Feb 2, 2026

Effect of Two Irrigation Protocols Applied Prior to Furcation Repair

An interventional study of Furcation Repair in Furcation Defects, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

  • Furcation Defects

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03

In context

Furcation Defects

42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.

This study's enrollment of 40 is above the median of 27 across 38 interventional studies indexed under Furcation Defects.

Browse Furcation Defects studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Teeth in need for post retained restoration.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    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.

    Procedure: Furcation Repair

  • Active comparator
    Group B

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

    Procedure: Furcation Repair

Interventions

  • ProcedureFurcation Repair

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

06

What researchers measure

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".

    Time frame: From 1 day to 7 days after The Procedure

Secondary outcomes

  1. Healing

    Furcation repair development will be evaluated by comparing the furcation radiolucency, pre-operatively and postoperatively (after3, 6 and 9 months), using periapical radiographs and CBCT. This will be aggregated in percentage (%).

    Time frame: From base line to 3,6 and 9 months

07

Study locations

1 site
  • Minia University, Faculty of Dentistry
    Minya, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06757660
Lead sponsor
Minia University
Responsible party
Shreef Mostafa Ibrahim (Assistant lecturer of Endodontics at Deraya University, minia, Minia University) — Principal investigator
First posted
Jan 3, 2025
Start date
Oct 10, 2023
Primary completion
Jul 15, 2024
Completion
Jul 20, 2024
Last update
Feb 2, 2026

Study contacts

Dalia Ali Moukarab, Professor
study chair · Endodontics,Faculty of Dentistry, Minia University
Esam Fawzy, Lecturer
study director · Department of Endodontics, Faculty of Dentistry Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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