An interventional study of Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft and Albumin Platelet-Rich Fibrin in Periodontitis, Periodontitis Stage III and Periodontal Intrabony Defects, sponsored by Halil Ata BIÇAKÇIOĞLU. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Halil Ata BIÇAKÇIOĞLU · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 24 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Halil Ata BIÇAKÇIOĞLU is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to the active comparator arm will undergo regenerative periodontal surgery. Following flap elevation and defect debridement, the root surface will be conditioned with EDTA, and an allogeneic bone graft will be placed within the intrabony periodontal defect.
Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft
Participants allocated to the experimental arm will undergo the same regenerative periodontal surgical procedure, including flap elevation, defect debridement, EDTA root surface conditioning, and placement of an allogeneic bone graft. Alb-PRF prepared from autologous venous blood will additionally be applied to the intrabony periodontal defect.
Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft · Other: Albumin Platelet-Rich Fibrin
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.
Also known as: Periodontal Regenerative Surgery
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.
Also known as: Alb-PRF
Clinical Attachment Level Gain
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.
Time frame: Baseline to 6 months
Probing Depth Reduction
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.
Time frame: Baseline, 3 months, 6 months, and 9 months
Radiographic Intrabony Defect Fill
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.
Time frame: Baseline to 9 months
Early Healing Index Score
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.
Time frame: 14 days after surgery
Postoperative Pain Intensity
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.
Time frame: Day 0, Day 7, and Day 14 after surgery
Oral Health-Related Quality of Life
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.
Time frame: Baseline, Day 14, and 9 months
Plaque Index Score
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.
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Index Score
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.
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Recession Depth
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.
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Recession Width
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.
Time frame: Baseline, 3 months, 6 months, and 9 months
Treatment-Related Adverse Events
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.
Time frame: From the surgical procedure through 9 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication will be made available upon reasonable request. Shared data may include baseline characteristics, treatment allocation, clinical and radiographic outcome data, patient-reported outcome data, and adverse event information. Data sharing will be subject to ethics committee requirements and institutional approval.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data and supporting information will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access criteria: Data may be provided to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator and the relevant institution. Access will be granted for approved scientific purposes following ethics committee and institutional requirements and, where applicable, execution of a data use agreement.
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Halil Ata BIÇAKÇIOĞLU