PeriodontitisNCT07794046
Alb-PRF as an Adjunct to Nonsurgical Periodontal Therapy
A study testing Nonsurgical Periodontal Therapy and Albumin Platelet-Rich Fibrin in people with Periodontitis, run by Halil Ata BIÇAKÇIOĞLU at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Nonsurgical Periodontal Therapy and Albumin Platelet-Rich Fibrin
- Type of treatment
- Pill or oral medicine, 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 Dec 2026to 1 Dec 2027
- 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 periodontitis according to the 2017 classification of periodontal and peri-implant diseases and conditions.
- Presence of at least two clinically comparable periodontal sites within the same mouth that are suitable for a split-mouth design.
- Periodontal probing depth of 5 mm or greater at the sites selected for randomization.
- No systemic condition that would contraindicate nonsurgical periodontal therapy or adversely affect periodontal healing.
- No current use of medications known to affect periodontal tissue healing.
- No periodontal surgical treatment within the previous 6 months.
- Ability to understand the study procedures, provide written informed consent, and attend the scheduled follow-up visits.
Who cannot join
- Current smoking or smoking cessation within the previous 6 months.
- Diabetes mellitus, uncontrolled hypertension, serious cardiovascular disease, autoimmune disease, liver failure, kidney failure, or another systemic condition that may adversely affect periodontal healing or treatment.
- Use of antibiotics, corticosteroids, bisphosphonates, antiresorptive agents, immunosuppressive agents, or other medications known to affect periodontal healing within the previous 6 months.
- Pregnancy or lactation.
- Acute periodontal abscess or acute endodontic infection at a selected study site.
- Hematologic disease, bleeding disorder, anticoagulant therapy, or another condition that may interfere with venous blood collection.
Show all 10Show fewer
- Known hypersensitivity to any material used in the study.
- Inadequate oral hygiene or inability to meet the oral hygiene 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
Çankırı Karatekin University Faculty of Dentistry, Department of Periodontology
Çankırı, Çankırı, 18100
Halil Ata Bıçakçıoğlu, PhD, +903762189578, halilbicakcioglu@karatekin.edu.tr
About this study
Official title: Clinical and Microbiological Effects of Intrapocket Albumin Platelet-Rich Fibrin as an Adjunct to Nonsurgical Periodontal Therapy: A Randomized Split-Mouth Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Periodontitis
- Being tested
- Nonsurgical Periodontal Therapy, Albumin Platelet-Rich Fibrin
- Keywords
- Albumin Platelet-Rich Fibrin, Alb-PRF, Nonsurgical Periodontal Therapy, Scaling and Root Planing, Intrapocket Application, Periodontal Pocket, Autologous Platelet Concentrate, Split-Mouth Clinical Trial, Subgingival Microbiota, Quantitative Real-Time PCR, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Prevotella intermedia
- Medical subject headings
- Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical Periodontal TherapyProcedure or surgery
Also called NSPT, Scaling and Root Planing, SRP
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.
Albumin Platelet-Rich FibrinOther
Also called Alb-PRF, Albumin-Enriched Platelet-Rich Fibrin
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.
| Study group | Role | What they receive |
|---|---|---|
| Nonsurgical Periodontal Therapy | Active comparator | 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. Receives: Procedure: Nonsurgical Periodontal Therapy |
| Nonsurgical Periodontal Therapy Plus Alb-PRF | Experimental | 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). Receives: Procedure: Nonsurgical Periodontal Therapy; Other: Albumin Platelet-Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From intervention administration through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (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
- This is a randomized split-mouth study. Within each participant, two clinically comparable periodontal sites will be assigned to the two intervention arms. One site will receive nonsurgical periodontal therapy alone, while the matched site will receive the same therapy followed by intrapocket Alb-PRF application. Both interventions will be administered during the same treatment period.
- 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
- 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
- NCT07794046
- Sponsor's protocol ID
- ALBPRF-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 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 publication may be shared upon reasonable request, subject to ethics committee requirements and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Effects of Intrapocket Albumin Platelet-Rich Fibrin as an Adjunct to Nonsurgical Periodontal Therapy: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07794046
- Acronym / sponsor ID
- ALBPRF-01
- Conditions
- Periodontitis
- Keywords
- Albumin Platelet-Rich Fibrin, Alb-PRF, Nonsurgical Periodontal Therapy, Scaling and Root Planing, Intrapocket Application, Periodontal Pocket, Autologous Platelet Concentrate, Split-Mouth Clinical Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Halil Ata BIÇAKÇIOĞLUUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Aug 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized split-mouth study. Within each participant, two clinically comparable periodontal sites will be assigned to the two intervention arms. One site will receive nonsurgical periodontal therapy alone, while the matched site will receive the same therapy followed by intrapocket Alb-PRF application. Both interventions will be administered during the same treatment period.
| Arm | Type | Receives |
|---|---|---|
| Nonsurgical Periodontal Therapy | Active comparator | Procedure: Nonsurgical Periodontal TherapyIn 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. |
| Nonsurgical Periodontal Therapy Plus Alb-PRF | Experimental | Procedure: Nonsurgical Periodontal Therapy, Other: Albumin Platelet-Rich FibrinIn 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). |
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 periodontitis according to the 2017 classification of periodontal and peri-implant diseases and conditions.
- Presence of at least two clinically comparable periodontal sites within the same mouth that are suitable for a split-mouth design.
- Periodontal probing depth of 5 mm or greater at the sites selected for randomization.
- No systemic condition that would contraindicate nonsurgical periodontal therapy or adversely affect periodontal healing.
Key exclusion criteria (10 listed)
- Current smoking or smoking cessation within the previous 6 months.
- Diabetes mellitus, uncontrolled hypertension, serious cardiovascular disease, autoimmune disease, liver failure, kidney failure, or another systemic condition that may adversely affect periodontal healing or treatment.
- Use of antibiotics, corticosteroids, bisphosphonates, antiresorptive agents, immunosuppressive agents, or other medications known to affect periodontal healing within the previous 6 months.
- Pregnancy or lactation.
- Acute periodontal abscess or acute endodontic infection at a selected study site.
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 |
|---|---|---|
| Nonsurgical Periodontal TherapyAlso: NSPT, Scaling and Root Planing, SRPNonsurgical 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. | Procedure or surgery | Nonsurgical Periodontal Therapy, Nonsurgical Periodontal Therapy Plus Alb-PRF |
| Albumin Platelet-Rich FibrinAlso: Alb-PRF, Albumin-Enriched Platelet-Rich FibrinAlb-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. | Other | Nonsurgical Periodontal Therapy Plus Alb-PRF |
Primary outcome
Change in Periodontal Probing Depth
Time frame: Baseline to 3 months
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.
6 secondary outcomes
Change in Clinical Attachment Level
Time frame: Baseline to 3 and 6 months
Change in Bleeding on Probing
Time frame: Baseline to 1, 3, and 6 months
Change in Plaque Index
Time frame: Baseline to 1, 3, and 6 months
Change in Gingival Index
Time frame: Baseline to 1, 3, and 6 months
Change in the Proportion of Sites With Periodontal Probing Depth of 5 mm or Greater
Time frame: Baseline to 3 and 6 months
Number of Participants With Alb-PRF-Related Local Adverse Events
Time frame: From intervention administration through 6 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 31 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
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 Nonsurgical Periodontal Therapy and Albumin Platelet-Rich Fibrin in people with Periodontitis, 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 10 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 31 Aug 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?
Change in Periodontal Probing Depth (time frame: Baseline to 3 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 31 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.