An interventional study of Nonsurgical Periodontal Therapy and Albumin Platelet-Rich Fibrin in Periodontitis, 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 2026-08-31.
Sponsored by Halil Ata BIÇAKÇIOĞLU · Not applicable, Interventional, and Treatment
Periodontitis is an inflammatory disease that damages the tissues supporting the teeth. Nonsurgical periodontal therapy is the standard initial treatment, but deep periodontal pockets may remain after treatment. Albumin platelet-rich fibrin (Alb-PRF) is an autologous material prepared from the participant's own blood and applied locally to support periodontal healing.
The main purpose of this study is to determine whether applying Alb-PRF into periodontal pockets in addition to nonsurgical periodontal therapy provides greater clinical improvement than nonsurgical periodontal therapy alone. The study will also evaluate whether the additional application of Alb-PRF affects the levels of selected bacteria associated with periodontitis.
This randomized split-mouth study will include 24 adults with periodontitis. In each participant, matched periodontal sites will be randomly assigned to receive either nonsurgical periodontal therapy alone or nonsurgical periodontal therapy followed by an intrapocket application of Alb-PRF. Clinical periodontal measurements will be recorded at baseline and at 1, 3, and 6 months. Subgingival plaque samples will be collected from the same sites at baseline and 30 days after treatment. The primary outcome is the reduction in periodontal probing depth from baseline to 3 months.
This study is designed as a multicenter, randomized, controlled, split-mouth clinical trial with a single-masked outcome assessment. A total of 24 adults with periodontitis and at least two clinically comparable periodontal sites suitable for a split-mouth comparison will be enrolled.
Within each participant, eligible periodontal sites will be randomly assigned to a control or test condition. Control sites will receive standard nonsurgical periodontal therapy, including oral hygiene instruction and supra- and subgingival mechanical debridement. Test sites will receive the same nonsurgical periodontal therapy followed by the local application of Alb-PRF into the periodontal pocket. Alb-PRF will be prepared from the participant's own venous blood under sterile conditions during the treatment visit.
Clinical periodontal assessments will be performed at baseline and at 1, 3, and 6 months. The clinical variables will include periodontal probing depth, clinical attachment level, bleeding on probing, plaque index, and gingival index. The examiner performing the clinical measurements will be masked to the site allocation. The primary outcome measure will be the change in periodontal probing depth from baseline to 3 months.
An integrated microbiological assessment will be conducted in the same participants, without enrolling a separate study population. Subgingival plaque samples will be collected from the randomized control and test sites at baseline and 30 days after treatment. The bacterial loads of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and Prevotella intermedia will be measured using quantitative real-time polymerase chain reaction. Changes in bacterial load between baseline and day 30 will be evaluated as exploratory outcomes and compared between the control and Alb-PRF-treated sites.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
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.
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.
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.
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.
In each participant, the periodontal site randomly assigned to the control arm will receive standard nonsurgical periodontal therapy, including oral hygiene instruction and supra- and subgingival mechanical debridement. No additional intrapocket material will be applied to the control site.
Procedure: Nonsurgical Periodontal Therapy
In each participant, the matched periodontal site randomly assigned to the experimental arm will receive the same nonsurgical periodontal therapy as the control site, followed by the local intrapocket application of autologous albumin platelet-rich fibrin (Alb-PRF).
Procedure: Nonsurgical Periodontal Therapy · Other: Albumin Platelet-Rich Fibrin
Nonsurgical periodontal therapy will include individualized oral hygiene instruction and supra- and subgingival mechanical debridement using periodontal hand instruments and/or ultrasonic devices. This intervention will be administered to the periodontal sites assigned to both study arms.
Also known as: NSPT, Scaling and Root Planing, SRP
Alb-PRF will be prepared under sterile conditions from autologous venous blood collected from each participant during the treatment visit. The albumin-containing plasma fraction will be heated at 75°C for 10 minutes and then combined with the appropriate liquid platelet-rich fibrin fraction to produce the Alb-PRF matrix. The freshly prepared Alb-PRF will be applied locally into the periodontal pocket immediately after nonsurgical periodontal therapy.
Also known as: Alb-PRF, Albumin-Enriched Platelet-Rich Fibrin
Change in Periodontal Probing Depth
Periodontal probing depth (PPD) will be measured in millimeters using a periodontal probe at the randomized control and Alb-PRF-treated sites. PPD reduction will be calculated by subtracting the 3-month PPD value from the baseline PPD value. A higher positive value indicates a greater reduction in probing depth.
Time frame: Baseline to 3 months
Change in Clinical Attachment Level
Clinical attachment level (CAL) will be measured in millimeters using a periodontal probe at the randomized control and Alb-PRF-treated sites. CAL gain will be calculated by subtracting the follow-up CAL value from the baseline CAL value. A higher positive value indicates greater clinical attachment gain.
Time frame: Baseline to 3 and 6 months
Change in Bleeding on Probing
Bleeding on probing (BOP) will be recorded as present or absent after gentle periodontal probing at the assessed sites. The result will be expressed as the percentage of sites showing bleeding, ranging from 0% to 100%. A lower percentage indicates less gingival inflammation.
Time frame: Baseline to 1, 3, and 6 months
Change in Plaque Index
Plaque accumulation will be assessed using the Silness and Löe Plaque Index. Each assessed surface will be scored from 0 to 3, with higher scores indicating greater plaque accumulation. Changes in Plaque Index scores will be compared between the study arms over time.
Time frame: Baseline to 1, 3, and 6 months
Change in Gingival Index
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each assessed surface will be scored from 0 to 3, with higher scores indicating greater gingival inflammation. Changes in Gingival Index scores will be compared between the study arms over time.
Time frame: Baseline to 1, 3, and 6 months
Change in the Proportion of Sites With Periodontal Probing Depth of 5 mm or Greater
The proportion of randomized periodontal sites with a periodontal probing depth of 5 mm or greater will be calculated for each study arm. The result will be expressed as a percentage ranging from 0% to 100%. A lower percentage at follow-up indicates a reduction in the number of residual deep periodontal sites.
Time frame: Baseline to 3 and 6 months
Number of Participants With Alb-PRF-Related Local Adverse Events
Participants will be assessed for local adverse events potentially related to intrapocket Alb-PRF application, including pain, tenderness, swelling, infection, and other unexpected local reactions. The occurrence and nature of each event will be recorded at treatment and follow-up visits.
Time frame: From intervention administration through 6 months
Change in Porphyromonas gingivalis Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Porphyromonas gingivalis bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame: Baseline to 30 days
Change in Aggregatibacter actinomycetemcomitans Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Aggregatibacter actinomycetemcomitans bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame: Baseline to 30 days
Change in Prevotella intermedia Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Prevotella intermedia bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame: Baseline to 30 days
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request, subject to ethics committee requirements and institutional approval.
Supporting information: Study protocol
Time frame: Data will be available beginning 6 months after publication of the 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. Data will be shared for approved scientific purposes following ethics and institutional requirements and, where applicable, execution of a data use agreement.
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Halil Ata BIÇAKÇIOĞLU