Periodontitis, Periodontitis Stage III, Periodontal Intrabony Defects
Conditions
Keywords
Albumin Platelet-Rich Fibrin, Alb-PRF, Regenerative Periodontal Surgery, Periodontal Intrabony Defect, Periodontal Regeneration, Allogeneic Bone Graft, EDTA Root Surface Conditioning, Clinical Attachment Level, Randomized Controlled Trial
Brief summary
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.
Interventions
PROCEDURERegenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft
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.
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.
Sponsors
Çankırı Karatekin University
Halil Ata BIÇAKÇIOĞLU
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical measurements and radiographic analyses will be performed by an examiner blinded to group allocation. The surgeon cannot be masked because of the nature of the intervention.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive regenerative periodontal surgery with EDTA root surface conditioning and an allogeneic bone graft, either alone or in combination with Alb-PRF.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level Gain | 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
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth Reduction | 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. |
| Radiographic Intrabony Defect Fill | 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. |
| Early Healing Index Score | 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. |
| Postoperative Pain Intensity | 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. |
| Oral Health-Related Quality of Life | 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. |
| Plaque Index Score | 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. |
| Gingival Index Score | 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. |
| Gingival Recession Depth | 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. |
| Gingival Recession Width | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHalil Ata Bıçakçıoğlu, PhD
CONTACTGülenay Çolak, DDS
PRINCIPAL_INVESTIGATORHalil Ata Bıçakçıoğlu, PhD
Çankırı Karatekin University
Outcome results
None listed