Furcation DefectsNCT06757660
Effect of Two Irrigation Protocols Applied Prior to Furcation Repair
A study testing Furcation Repair in people with Furcation Defects, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Furcation Defects
- What is being tested?
- Furcation Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Irrigation Protocols Applied Prior to Furcation Repair on Post Operative Pain and Healing (A Randomized Clinical Trial)
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.
- Conditions
- Furcation Defects
- Being tested
- Furcation Repair
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furcation RepairProcedure or surgery
to evaluate the clinical and radiographic effects of chitosan and Naocl as an irrigation protocols applied during repair of furcation perforation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Furcation Repair |
| Group B | Active comparator | About 20 patients will be irrigated with nanoparticle chitosan (2 %). Receives: Procedure: Furcation Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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 (%).
Measured: From base line to 3,6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start10 Oct 2023
- Primary completion15 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Furcation DefectsStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreef Mostafa Ibrahim, Minia University
- Investigators
- Dalia Ali Moukarab, Professor, Study chair, Endodontics,Faculty of Dentistry, Minia UniversityEsam Fawzy, Lecturer, Study director, Department of Endodontics, Faculty of Dentistry Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757660
- Sponsor's protocol ID
- Shreef Mostafa
- Status last verified
- Oct 2023
- First submitted
- 27 Dec 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Irrigation Protocols Applied Prior to Furcation Repair on Post Operative Pain and Healing (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06757660
- Acronym / sponsor ID
- Shreef Mostafa
- Conditions
- Furcation Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Furcation RepairAbout 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 B | Active comparator | Procedure: Furcation RepairAbout 20 patients will be irrigated with nanoparticle chitosan (2 %). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furcation Repairto evaluate the clinical and radiographic effects of chitosan and Naocl as an irrigation protocols applied during repair of furcation perforation. | Procedure or surgery | Group A, Group B |
Primary outcome
Postoperative pain
Time frame: From 1 day to 7 days after The Procedure
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".
1 secondary outcome
Healing
Time frame: From base line to 3,6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Furcation Defects
RecruitingPhase 3
Treatment of Class II Mandibular Furcation Defects
Class II Furcation Defect
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Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects
Injectable Platelet-Rich Fibrin, Minimally Invasive
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Recruiting
Morphological Characteristics of Mandibular Molar Furcation Involvement and Efficacy of Regenerative Surgical Treatment
Periodontitis, Periodontitis (Stage 3)
Recruiting
Efficacy of PRF and Xenograft in Treating Mandibular Molar Furcation Involvements
Periodontitis, Furcation Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furcation Repair in people with Furcation Defects, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: From 1 day to 7 days after The Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.