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

Injectable Platelet Rich Fibrin (I-PRF) With Xenograft in Intrabony Defects of Periodontitis Patient Stage III Versus Xenograft Alone

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

Study Overview

• Status: Active, not recruiting
• Conditions: Intrabony Defect; Intrabony Defects in Chronic Periodontitis
• Intervention / Treatment: Procedure: injectable platelet rich fibrin and xenograft; Procedure: 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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Faculty of Dental Medicine for Girls, Al- Azhar University
    • Cairo, Cairo Governorate, Egypt
      • Ola Jamal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: 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; 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
Active Comparator: 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	Procedure: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic parameters	• The bone fill after 6 months postoperatively using digital periapical radiography using parallel technique.	6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth (PD)	will be assessed by William graduated periodontal Probe in 4 surfaces of the tooth	presurgically, 3 and 6 months interval after treatment
Plaque index (PI)	According to Silness & Loe, 4 readings will be recorded for each surface of the teeth (buccal, lingual, mesial and distal) and it is given a score from 0-3	pre-surgically 3 months and 6 months respectively
Gingival index (GI)	presence or absence of bleeding on upon gentle probing	pre-surgically 3 months and 6 months respectively
Clinical attachment level (CAL)	will be measured from the cement-enamel junction to the base of the pocket	pre-surgically 3 months and 6 months respectively

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Eatemad Ahmed Shoreibah A Shoreibah, Professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Actual): February 18, 2025
• Study Completion (Estimated): December 17, 2026

Study Registration Dates

• First Submitted: August 21, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: I-PRF with xenograft
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous
• Other Study ID Numbers: P-ME-24-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No