Treatment of Class II Mandibular Furcation Defects

NCT07876973 | Recruiting Phase 3 DMC

• 1 other identifier: mandibular FI defect treatment
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the clinical efficiency and radiographic outcomes following minimally invasive surgical technique with xenograft and i-PRF versus i-PRF in the management of class II furcation defects in mandibular molars

Conditions

Class II Furcation Defect

Outcome Measures

Primary Outcomes (1)

• difference in probing depth

  It is measured in milimeters using UNC 15 periodontal probe that inserted in the buccal gingival sulcus in the area corresponding to the furcation defect with a force not exceed 25 g

  at baseline,6 months,12 months follow up

Secondary Outcomes (7)

• linear bone fill

  at baseline,6 months,12 months follow up

• clinical attachment level gain (CAL gain)

  at 6 months and 12 months follow up

• plaque index

  at baseline, 6months &12months follow up

• Horizontal probing pocket depth

  at baseline, 6months &12months follow up

• patient satisfaction

  at baseline, 6months &12months follow up.

Study Arms (2)

Injectable-PRF (I-PRF)

EXPERIMENTAL

I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately). The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.

Biological: Injectable-PRF (I-PRF)

sticky bone (I-PRF+Xenograft)

ACTIVE COMPARATOR

The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect. The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.

Biological: sticky bone (I-PRF+Xenograft)

Interventions

Injectable-PRF (I-PRF) BIOLOGICAL

I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately). The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.

Injectable-PRF (I-PRF)

sticky bone (I-PRF+Xenograft) BIOLOGICAL

The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect. The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.

sticky bone (I-PRF+Xenograft)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with healthy systemic condition
• Adult patients (18 years old and older)
• Patients with stage lll or IV periodontitis.
• Patients having a buccal or lingual degree II A or B furcation defect in periapical-lesion free and not mobile first or second mandibular molars with horizontal attachment loss HCAL \>3 mm and probing depth PD ≥5 mm in the mid-buccal or mid-lingual sites when evaluated 12 weeks after non-surgical periodontal therapy.
• Patients with full mouth plaque score\<10% on the day of the surgery.
• Patients with full mouth bleeding score\<10% on the day of the surgery.
• Compliance with good oral hygiene.
• Patients accept 12-months follow-up period (cooperative patients).
• Patients provide an informed consent.

You may not qualify if:

• Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
• Defects that involve the buccal and lingual sites.
• Smokers ˃ 10 cigarettes / day
• Pregnant and lactating female

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry,Cairo University

Cairo, Cairo Governorate, 35855, Egypt

RECRUITING

Study Officials

• Alhussien A Ahmed mohamed, Master candidate

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alhussien A Ahmed mohamed, master candidate

CONTACT

00201014788705; alhussien.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master candidate

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)