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

Official title

Evaluation of the Effect of Injectable Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects With Xenogenic Grafts: a Randomized Controlled Clinical Trial

Overview

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.

Interventions

• Procedure 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
• 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 phy

Primary outcome measures

• Intrabony Defect Fill [Time frame: At enrollment and 6 months control visit]
• Clinical Attachment Level [Time frame: At enrollment, 3 and 6 months control visits]

Secondary outcome measures (5)

• Probing Pocket Depth [Time frame: At enrollment, 3 and 6 months control visits]
• Plaque Index [Time frame: At enrollment, 3 and 6 months control visits]
• Gingival Index [Time frame: At enrollment, 3 and 6 months control visits]
• Pain Assasment [Time frame: 2 weeks after the surgical intervention]
• The Amount of Painkiller Used [Time frame: 2 weeks after the surgical intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Sağlık Bilimleri Üniversitesi — Istanbul

Identifiers

NCT: NCT07146776 · 25-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗