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NCT Number: NCT07805317

Alb-PRF as an Adjunct to Regenerative Periodontal Surgery

Periodontitis is characterized by the progressive destruction of tooth-supporting tissues and may lead to the formation of intrabony periodontal defects. Regenerative periodontal surgery aims to promote the reconstruction of the periodontal attachment apparatus and reduce residual defect dimensions. Albumin platelet-rich fibrin (Alb-PRF) is an autologous blood-derived biomaterial that combines an albumin-based matrix with platelet-rich fibrin components.

This randomized controlled clinical trial will evaluate the clinical and radiographic effects of Alb-PRF as an adjunct to regenerative periodontal surgery in patients with periodontitis-associated intrabony defects. Twenty-four participants will be randomly allocated to two parallel treatment groups. Both groups will undergo regenerative periodontal surgery involving defect debridement, root surface conditioning with EDTA, and placement of an allogeneic bone graft. In the experimental group, Alb-PRF will additionally be applied to the intrabony defect.

The primary outcome will be clinical attachment level gain at 6 months. Secondary outcomes will include probing depth, radiographic defect fill, early wound healing, postoperative pain, oral health-related quality of life, and adverse events. Participants will be followed for 9 months.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Periodontal Intrabony Defects Periodontitis Stage III Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Dentistry, Department of Periodontology, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 65 years.
  • Diagnosis of Stage III periodontitis according to the 2017 classification of periodontal and peri-implant diseases and conditions.
  • Completion of nonsurgical periodontal therapy and oral hygiene instruction before surgical treatment.
  • Presence of at least one interproximal intrabony periodontal defect considered suitable for regenerative periodontal surgery.
  • Residual probing depth of at least 6 mm and clinical attachment loss of at least 6 mm at the selected site following nonsurgical periodontal therapy.
  • Radiographic evidence of an intrabony defect component of at least 3 mm at the selected site.
  • Adequate plaque control and compliance with oral hygiene instructions.
  • Ability to understand the study procedures, provide written informed consent, and attend all scheduled follow-up visits.

Exclusion criteria

  • Current smoking or smoking cessation within the previous 6 months.
  • Uncontrolled diabetes mellitus, serious cardiovascular disease, autoimmune disease, liver or kidney failure, immunodeficiency, or another systemic condition that may adversely affect periodontal healing or surgical treatment.
  • Pregnancy or lactation.
  • Presence of a hematologic disorder, bleeding disorder, anticoagulant therapy, or another condition that may interfere with venous blood collection or periodontal surgery.
  • Use of antibiotics, systemic corticosteroids, immunosuppressive agents, bisphosphonates, antiresorptive agents, or other medications known to affect periodontal or bone healing within the previous 6 months.
  • Periodontal surgical treatment at the selected site within the previous 6 months.
  • Acute periodontal or endodontic infection at the selected site.
  • Untreated endodontic lesions, root fractures, extensive caries, or a hopeless prognosis involving the selected tooth.
  • Class II or III furcation involvement associated with the selected defect.
  • Known hypersensitivity to any material used in the study.
  • Inadequate oral hygiene or inability to meet the plaque-control requirements of the study protocol.
  • Current orthodontic treatment.
  • Inability or unwillingness to attend the scheduled follow-up visits.

Treatment and study plan

Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft

Procedure

Following local anesthesia, a periodontal flap will be elevated to provide access to the intrabony defect. Granulation tissue will be removed, and the exposed root surface will be thoroughly debrided and conditioned with EDTA. An allogeneic bone graft will then be placed within the defect, and the surgical site will be closed using appropriate suturing techniques. This intervention will be administered to participants in both study arms.

Other names: Periodontal Regenerative Surgery

Albumin Platelet-Rich Fibrin

Other

Alb-PRF will be prepared from autologous venous blood using a standardized centrifugation and albumin-processing protocol. The resulting albumin-based platelet-rich fibrin biomaterial will be combined with or applied in conjunction with the allogeneic bone graft and placed within the intrabony periodontal defect during regenerative periodontal surgery.

Other names: Alb-PRF

Primary outcomes

  1. Clinical Attachment Level Gain

    Time frame: Baseline to 6 months

    Clinical attachment level will be measured in millimeters at the treated intrabony defect site from the cementoenamel junction to the base of the periodontal pocket using a calibrated periodontal probe. Clinical attachment level gain will be calculated as the baseline value minus the 6-month value. Higher positive values indicate greater clinical attachment gain.

Secondary outcomes

  1. Probing Depth Reduction

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Probing depth will be measured in millimeters at the treated intrabony defect site from the gingival margin to the base of the periodontal pocket using a calibrated periodontal probe. Probing depth reduction will be calculated as the baseline value minus the value recorded at each follow-up visit. Higher positive values indicate greater probing depth reduction.

  2. Radiographic Intrabony Defect Fill

    Time frame: Baseline to 9 months

    Radiographic intrabony defect depth will be measured on standardized digital periapical radiographs obtained at baseline and 9 months. Defect fill will be calculated as the reduction in radiographic defect depth relative to the baseline defect depth and expressed as a percentage. Higher percentages indicate greater radiographic defect fill.

  3. Early Healing Index Score

    Time frame: 14 days after surgery

    Early postoperative wound healing will be evaluated using the Early Healing Index. The index ranges from 1 to 5 and assesses flap closure, fibrin formation, and the presence of tissue necrosis at the surgical site. Lower scores indicate more favorable early wound healing.

  4. Postoperative Pain Intensity

    Time frame: Day 0, Day 7, and Day 14 after surgery

    Postoperative pain intensity will be assessed using a visual analog scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less postoperative pain.

  5. Oral Health-Related Quality of Life

    Time frame: Baseline, Day 14, and 9 months

    Oral health-related quality of life will be evaluated using the 14-item Oral Health Impact Profile. Each item is scored from 0 to 4, producing a total score ranging from 0 to 56. Lower total scores indicate a lower negative impact of oral health conditions on quality of life.

  6. Plaque Index Score

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Plaque accumulation will be assessed using the Silness and Löe Plaque Index. Each evaluated surface will be scored from 0 to 3, where 0 indicates the absence of plaque and 3 indicates abundant plaque accumulation. Lower scores indicate better plaque control.

  7. Gingival Index Score

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each evaluated surface will be scored from 0 to 3 according to changes in gingival color, consistency, and bleeding response. Lower scores indicate less gingival inflammation.

  8. Gingival Recession Depth

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Gingival recession depth will be measured in millimeters at the treated tooth as the apicocoronal distance from the cementoenamel junction to the gingival margin using a calibrated periodontal probe. Higher values indicate greater apical displacement of the gingival margin.

  9. Gingival Recession Width

    Time frame: Baseline, 3 months, 6 months, and 9 months

    Gingival recession width will be measured in millimeters at the treated tooth as the mesiodistal width of the exposed root surface at the level of the cementoenamel junction using a calibrated periodontal probe. Higher values indicate a wider gingival recession defect.

Other outcomes

  1. Treatment-Related Adverse Events

    Time frame: From the surgical procedure through 9 months

    Participants will be monitored for treatment-related adverse events, including postoperative infection, excessive or prolonged bleeding, marked swelling, wound dehiscence, graft exposure, delayed healing, and any other unexpected complication associated with the surgical procedure or Alb-PRF application. The number and proportion of participants experiencing at least one adverse event will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Gülenay Çolak, DDS

CONTACT

[email protected]

+903122034000

Halil Ata Bıçakçıoğlu, PhD

CONTACT

[email protected]

+903762189578

Sponsors and collaborators

Lead sponsor

Halil Ata BIÇAKÇIOĞLU

Other

Collaborators

  • Gazi University
  • Çankırı Karatekin University

Registry information

Official study title

Clinical and Radiographic Effects of Albumin Platelet-Rich Fibrin as an Adjunct to Regenerative Periodontal Surgery: A Randomized Controlled Clinical Trial

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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