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

NCT07146776 | Recruiting

• 1 other identifier: 25-19
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

i-prf; injectable prf; injectable platelet rich fibrin; xenogenic graft; xenogenic bone graft; xenograft

Outcome Measures

Primary Outcomes (2)

• Intrabony Defect Fill

  The change in the defect size will be evaluated using computed tomography. Slices with a thickness of 1.0 mm will be acquired in the sagittal plane. The defect base, alveolar bone crest, and cementoenamel junction (CEJ) will be identified on the images, and the distances between these anatomical landmarks will be measured in millimeters. The distance between the defect base and the alveolar bone crest will be used to determine the depth of the intraosseous defect.

  At enrollment and 6 months control visit

• Clinical Attachment Level

  It represents the value obtained by measuring the distance between the pocket base and the cementoenamel junction (CEJ) using a standard periodontal probe with a diameter of 0.4-0.5 mm, rounded to the nearest millimeter. The changes in clinical attachment level will be measured at baseline, as well as at the 3- and 6-month follow-up visits.

  At enrollment, 3 and 6 months control visits

Secondary Outcomes (5)

• Probing Pocket Depth

  At enrollment, 3 and 6 months control visits

• Plaque Index

  At enrollment, 3 and 6 months control visits

• Gingival Index

  At enrollment, 3 and 6 months control visits

• Pain Assasment

  2 weeks after the surgical intervention

• The Amount of Painkiller Used

  2 weeks after the surgical intervention

Study Arms (2)

i-PRF and xenogenic graft

EXPERIMENTAL

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.

Procedure: open flap debridement with I-prf and xenogeneic graft

Saline and xenogenic graft

ACTIVE COMPARATOR

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.

Procedure: open flap debridement with saline and xenogenic graft

Interventions

open flap debridement with I-prf and xenogeneic graft 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.

i-PRF and xenogenic graft

open flap debridement with saline and xenogenic graft 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.

Saline and xenogenic graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Istanbul, Üsküdar, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Alveolar Bone Loss

Interventions

proliferation regulatory factors, human urine; Sodium Chloride

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Tuğçe Paksoy, Associate Professor

CONTACT

+905534490452; tugceakap86@hotmai.com

Alima Budakçı

CONTACT

+905319841597; alima-97@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: July 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

TU (1)