PeriodontitisNCT07805317
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
A study testing Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft and Albumin Platelet-Rich Fibrin in people with Periodontitis and Periodontitis Stage III, run by Halil Ata BIÇAKÇIOĞLU at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Periodontitis Stage III, Periodontal Intrabony Defects
- What is being tested?
- Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft and Albumin Platelet-Rich Fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Gazi University Faculty of Dentistry, Department of Periodontology
Ankara, Ankara, 06490
Gülenay Çolak, DDS, +903122034000, gulenaycolak@gazi.edu.tr
Gülenay Çolak, DDS
Çankırı Karatekin University Faculty of Dentistry, Department of Periodontology
Çankırı, Çankırı, 18100
Halil Ata Bıçakçıoğlu, PhD, +903762189578, halilbicakcioglu@karatekin.edu.tr
Halil Ata Bıçakçıoğlu, PhD
About this study
Official title: Clinical and Radiographic Effects of Albumin Platelet-Rich Fibrin as an Adjunct to Regenerative Periodontal Surgery: A Randomized Controlled Clinical Trial
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.
- Being tested
- Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft, Albumin Platelet-Rich Fibrin
- 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
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Periodontal Surgery With EDTA and Allogeneic Bone GraftProcedure or surgery
Also called Periodontal Regenerative Surgery
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.
Albumin Platelet-Rich FibrinOther
Also called Alb-PRF
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.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative Periodontal Surgery With Allogeneic Bone Graft | Active comparator | 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. Receives: Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft |
| Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRF | Experimental | 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. Receives: Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft; Other: Albumin Platelet-Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halil Ata BIÇAKÇIOĞLU
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University, Çankırı Karatekin University
- Responsible party
- Sponsor-investigator, Halil Ata BIÇAKÇIOĞLU, Çankırı Karatekin University
- Investigators
- Halil Ata Bıçakçıoğlu, PhD, Principal investigator, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805317
- Sponsor's protocol ID
- ALBPRF-02
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Effects of Albumin Platelet-Rich Fibrin as an Adjunct to Regenerative Periodontal Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07805317
- Acronym / sponsor ID
- ALBPRF-02
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Halil Ata BIÇAKÇIOĞLUUniversity, hospital or other
- Collaborators
- Gazi University, Çankırı Karatekin University
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regenerative Periodontal Surgery With Allogeneic Bone Graft | Active comparator | Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone GraftParticipants 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. |
| Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRF | Experimental | Procedure: Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft, Other: Albumin Platelet-Rich FibrinParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative Periodontal Surgery With EDTA and Allogeneic Bone GraftAlso: Periodontal Regenerative SurgeryFollowing 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. | Procedure or surgery | Regenerative Periodontal Surgery With Allogeneic Bone Graft, Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRF |
| Albumin Platelet-Rich FibrinAlso: Alb-PRFAlb-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 | Regenerative Periodontal Surgery With Allogeneic Bone Graft and Alb-PRF |
Primary outcome
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.
9 secondary outcomes
Probing Depth Reduction
Time frame: Baseline, 3 months, 6 months, and 9 months
Radiographic Intrabony Defect Fill
Time frame: Baseline to 9 months
Early Healing Index Score
Time frame: 14 days after surgery
Postoperative Pain Intensity
Time frame: Day 0, Day 7, and Day 14 after surgery
Oral Health-Related Quality of Life
Time frame: Baseline, Day 14, and 9 months
Plaque Index Score
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Index Score
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Recession Depth
Time frame: Baseline, 3 months, 6 months, and 9 months
Gingival Recession Width
Time frame: Baseline, 3 months, 6 months, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Halil Ata Bıçakçıoğlu, PhD principal investigator
Çankırı Karatekin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Periodontal Surgery With EDTA and Allogeneic Bone Graft and Albumin Platelet-Rich Fibrin in people with Periodontitis and Periodontitis Stage III, run by Halil Ata BIÇAKÇIOĞLU at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halil Ata Bıçakçıoğlu, PhD (+903762189578, halilbicakcioglu@karatekin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level Gain (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.