Treatment of Intrabony Defect in Patient With Periodontitis Stage III by Using I-PRF and Xenograft

NCT ID: NCT07261878

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-12-17

Brief Summary

Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone.

Detailed Description

All surgical procedures will be conducted by a single operator. Following administration of local anesthesia, intrasulcular incisions will beperformed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded. In the group1: xenograft alone(Bovin xenograft)will be applied to the intrabony defect area. In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area. Preperation of Injectable platelate Rich Fibrin (I-PRF) : will be prepared for each patient as follows: 5 ml of venous blood will be collected from the patient blood then placed in a plastic tube without any added material or coagulant and centrifuged at 700 rpm for 3 min. then mixed with Xenograft. Finally, the flap will be passively repositioned using interrupted 4-0 silk

Conditions

Intrabony Defect; Intrabony Defects in Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

injectable platelet rich fibrin and xenograft

Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded .In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area.

Group Type: OTHER

injectable platelet rich fibrin and xenograft

Intervention Type: PROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals

Xenograft alone

Intervention Type: PROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals

xenograft alone

Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded, inserting the xenograft to the defect

Group Type: ACTIVE_COMPARATOR

injectable platelet rich fibrin and xenograft

Intervention Type: PROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals

Xenograft alone

Intervention Type: PROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals

Interventions

injectable platelet rich fibrin and xenograft

Elevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals

Intervention Type: PROCEDURE

Xenograft alone

Elevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient should have localized Periodontitis stage III grade B with pocket depth ≥ 6mm; indicated for periodontal surgery

2. Patient's agreement to the surgical procedure and clinical trial.

3. Age ranged between 30-55 years old.

4. Intrabony defects with depth ≥3mm.

5. Free from any systemic conditions and no previous drug affect bone metabolism

Exclusion Criteria

1. Smoking.

2. Pregnant women.

3. Patients in variation in anatomical landmarks.

4. Patients with psychological problems.

5. Patients with abnormal habits.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ola Alsareh

Oral Medicine, Periodontology, Oral Diagnosis and Radiology Department Faculty of Dental Medicine for Girls Al-Azhar University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eatemad Ahmed Shoreibah A Shoreibah, Professor

Role: STUDY_CHAIR

Al-Azhar University

Locations

Faculty of Dental Medicine for Girls, Al- Azhar University

Cairo, Cairo Governorate, Egypt

Ola Jamal

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P-ME-24-05

Identifier Type: -

Identifier Source: org_study_id