Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts

NCT ID: NCT07146776

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-12
• Study Completion Date: 2026-07-01

Brief Summary

The use of injectable platelet-rich fibrin (i-PRF) in both surgical and non-surgical dental treatments has become increasingly widespread. Hard tissue grafts can produce "sticky bone," and bone gain can have a positive effect on intrabony defects frequently seen in periodontal disease, compared to grafts alone. This study aims to clinically and radiographically evaluate the effectiveness of using bovine-derived xenogenic bone grafts in combination with i-PRF and bovine-derived xenogeneic bone grafts alone in patients with intrabony defects and stage III periodontitis.

Detailed Description

Intrabony defects are frequently observed in periodontitis patients. Bovine-derived xenogenic grafts are widely used in their treatment. To date, the graft has been mixed with various materials to increase its regenerative efficacy. In recent years, studies have explored its use in combination with PRF derivatives. Furthermore, with the introduction of i-PRF in regenerative treatments, its application with various biomaterials has been attempted. Applications have been made with materials such as demineralized freeze-dried bone allografts, hydroxyapatite bone grafts, and nanohydroxyapatite, with successful results. However, no studies have been conducted to date on the application of i-PRF with bovine-derived xenogeneic grafts in intrabony periodontal defects. This study aims to demonstrate that bovine-derived xenogeneic graft materials, which are frequently preferred by patients, achieve more successful results in various clinical and radiographic parameters in the treatment of intrabony defects, thanks to the contribution of i-PRF. The aims are to reduce clinical parameters that favor the treatment, increase bone fill, and minimize the defect area. It is thought that the use of I-PRF, a tissue-friendly biological material, will contribute to positive results in these parameters.

Conditions

Periodontitis; Intrabony Periodontal Defect; Periodontal Diseases; Periodontal Defect; Periodontal Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

i-PRF and xenogenic graft

In this treatment protocol, bone graft and i-PRF will be used instead of physiological saline. The preparation time for i-PRF (centrifugation) is 3 minutes. Two 9-mL tubes of venous blood will be collected from each patient.

Group Type: EXPERIMENTAL

open flap debridement with I-prf and xenogeneic graft

Intervention Type: PROCEDURE

During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be completely removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. Subsequently, a xenogeneic bone graft mixed with injectable platelet-rich fibrin (i-PRF) will be applied. The flap will then be sutured using 4-0 polypropylene sutures.

Saline and xenogenic graft

A bovine-derived xenogeneic bone graft, which is routinely used for the treatment of intraosseous defects, will be applied. The graft will be mixed with physiological saline prior to application.

Group Type: ACTIVE_COMPARATOR

open flap debridement with saline and xenogenic graft

Intervention Type: PROCEDURE

During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be thoroughly removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. A xenogeneic bone graft mixed with physiological saline will then be applied. Finally, the flap will be sutured using 4-0 polypropylene sutures.

Interventions

open flap debridement with I-prf and xenogeneic graft

During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be completely removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. Subsequently, a xenogeneic bone graft mixed with injectable platelet-rich fibrin (i-PRF) will be applied. The flap will then be sutured using 4-0 polypropylene sutures.

Intervention Type: PROCEDURE

open flap debridement with saline and xenogenic graft

During the surgical phase of treatment, patients will undergo open flap debridement surgery. Infiltrative local anesthesia will first be administered to the involved teeth. The gingiva will be incised within the gingival sulcus using a scalpel, and a full-thickness flap will be carefully elevated with a periosteal elevator. Granulation tissue and dental calculus will be thoroughly removed using Gracey curettes (American Eagle, USA) and an ultrasonic scaler. A xenogeneic bone graft mixed with physiological saline will then be applied. Finally, the flap will be sutured using 4-0 polypropylene sutures.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male and female patients aged 18-65 years
• Patients with Stage III Periodontitis according to the AAP-EFP 2017 Periodontal Disease Classification
• PPD≥5 mm (if persistent 6 weeks after initial periodontal treatment)
• Intrabony defects in the interproximal region with 2 or 3 walls and a depth of at least ≥3 mm
• Non-smokers (those who smoke up to 10 per day may be included)

Exclusion Criteria

• Patients under 18 years of age or older than 65 years of age
• Patients unable to consent
• Systemic diseases that could affect the success of surgery, such as uncontrolled diabetes
• Single-walled intrabony defects
• Those who have taken antibiotics, anti-inflammatory or immunosuppressive drugs, or birth control pills within the three months prior to the study
• Those who have received active periodontal treatment within the last six months and periodontal surgery within the last year
• Smoking more than 10 cigarettes per day
• Pregnancy or breastfeeding
• Those taking medications that affect the gums (e.g., calcium channel blockers, phenytoin or cyclosporine)
• Teeth with furcation defects
• Those undergoing active orthodontic treatment
• Those who are allergic to the biomaterials used in the study or prescribed medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Tuğçe Paksoy

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sağlık Bilimleri Üniversitesi

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Tuğçe Paksoy, Associate Professor

Role: CONTACT

tugceakap86@hotmai.com

+905534490452

Alima Budakçı

Role: CONTACT

alima-97@hotmail.com

+905319841597

Facility Contacts

Tuğçe Paksoy, Associate Professor

Role: primary

tugceakap86@hotmai.com

+905534490452

Other Identifiers

25-19

Identifier Type: -

Identifier Source: org_study_id