PeriodontitisNCT07415148
Hyaluronic Acid and Albumin-PRF in Non-Surgical Periodontal Therapy
A study testing Non-Surgical Periodontal Treatment, Albumin Platelet-Rich Fibrin (Alb-PRF) and Hyaluronic Acid Gel in people with Periodontitis and Periodontal Inflammation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Periodontitis, Periodontal Inflammation
- What is being tested?
- Non-Surgical Periodontal Treatment, Albumin Platelet-Rich Fibrin (Alb-PRF) and Hyaluronic Acid Gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy individuals aged between 30 and 60 years
- No history of periodontal treatment or antibiotic use within the last 6 months
- Non-smokers
- Accepting to regularly attend the follow-up sessions planned during the study period
- Diagnosis of Stage III periodontitis
- Presence of at least 15 teeth in the oral cavity, with more than 30% of the existing teeth affected by periodontal disease
Show all 9Show fewer
- Presence of probing pocket depth ≥6 mm and clinical attachment loss ≥5 mm in affected teeth
- Presence of vertical bone loss ≥3 mm
- Radiographic evidence of alveolar bone loss extending to the middle third or beyond (≥33%) of the root length in affected teeth
Who cannot join
- Presence of any systemic disease
- History of periodontal treatment or antibiotic use within the last 6 months
- Pregnancy or lactation
- Presence of acute oral lesions or necrotizing ulcerative periodontitis
- Use of medications known to affect periodontal tissues
- Current smoking
- Presence of immune system disorders or use of immunosuppressive medications
- Presence of prosthetic restorations on teeth selected for gingival crevicular fluid sampling
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, Battalgazi, 44280
About this study
Official title: Evaluation of the Effects of Hyaluronic Acid and Albumin-PRF as Adjuncts to Non-Surgical Periodontal Treatment on Clinical and Biochemical Parameters
Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes.
The aim of this randomized clinical trial is to evaluate the effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) used as adjuncts to non-surgical periodontal treatment on clinical and biochemical parameters in patients with Stage III periodontitis. Participants will be randomly allocated into three groups: an Alb-PRF group, a hyaluronic acid gel group, and a control group receiving non-surgical periodontal treatment alone. Clinical periodontal parameters and biochemical markers obtained from gingival crevicular fluid will be assessed at baseline and at 1 and 3 months after treatment. The findings of this study are expected to contribute to the evaluation of the potential benefits of adjunctive biological and anti-inflammatory applications in the non-surgical periodontal treatment of patients with Stage III periodontitis.v
Read the detailed description
This study is designed as a randomized, parallel-group clinical trial conducted in patients diagnosed with Stage III periodontitis. The aim of the study is to evaluate the adjunctive effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) when used in addition to non-surgical periodontal treatment.
A total of 51 systemically healthy volunteers will be included in the study. Participants will be randomly allocated into three groups (17 patient per group). At the initial visit, all participants will undergo clinical periodontal examination, intraoral photography, and gingival crevicular fluid sampling. Supragingival scaling will be performed for all patients at baseline. One week later, full-mouth scaling and root planing will be completed in a single session.
In the Alb-PRF group, albumin platelet-rich fibrin will be applied as an adjunctive therapy. In the hyaluronic acid group, hyaluronic acid gel will be applied following scaling and root planing and the application will be repeated at the second week. The control group will receive non-surgical periodontal treatment alone without any adjunctive application. Adjunctive treatments will be applied subgingivally immediately after periodontal therapy and one week later.
To evaluate clinical and biochemical outcomes, clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and at 1 and 3 months after treatment. Gingival crevicular fluid samples will be obtained using sterile paper strips as a non-invasive method. All collected data will be evaluated at the end of the study. The results of this study are expected to provide additional evidence regarding the effectiveness of adjunctive biological and anti-inflammatory approaches in the non-surgical treatment of Stage III periodontitis.
- Conditions
- Periodontitis, Periodontal Inflammation
- Being tested
- Non-Surgical Periodontal Treatment, Albumin Platelet-Rich Fibrin (Alb-PRF), Hyaluronic Acid Gel
- Keywords
- Periodontal Disease, Hyaluronic Acid, Albumin Platelet-Rich Fibrin, Scaling and Root Planing
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal TreatmentProcedure or surgery
Also called Scaling and Root Planing
Supragingival scaling was performed at baseline. One week later, full-mouth scaling and root planing were completed in a single session using standard periodontal instruments.
Albumin Platelet-Rich Fibrin (Alb-PRF)Other
Albumin platelet-rich fibrin (Alb-PRF) was applied subgingivally as an adjunctive therapy immediately after non-surgical periodontal treatment, with a second application performed one week later.
Hyaluronic Acid GelOther
Also called Hyaluronic acid (HA), HA gel
Hyaluronic acid gel was applied subgingivally as an adjunct to non-surgical periodontal treatment immediately after the procedure, with a second application performed one week later.
| Study group | Role | What they receive |
|---|---|---|
| Alb-PRF | Experimental | Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF). Receives: Procedure: Non-Surgical Periodontal Treatment; Other: Albumin Platelet-Rich Fibrin (Alb-PRF) |
| Hyaluronic Acid | Experimental | Participants receive non-surgical periodontal treatment with adjunctive hyaluronic acid gel application. Receives: Procedure: Non-Surgical Periodontal Treatment; Other: Hyaluronic Acid Gel |
| Control Group | Active comparator | Participants receive non-surgical periodontal treatment alone without any adjunctive application. Receives: Procedure: Non-Surgical Periodontal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid VEGF Levels
Changes in vascular endothelial growth factor (VEGF) levels in gingival crevicular fluid will be analyzed to evaluate angiogenic activity.
Measured: Baseline, 1. month and 3. months
Change in Gingival Crevicular Fluid IL-1 Beta Levels
Changes in interleukin-1 beta (IL-1β) levels in gingival crevicular fluid will be assessed as a marker of inflammation.
Measured: Baseline, 1. month and 3. months
Change in Gingival Crevicular Fluid IL-10 Levels
Changes in interleukin-10 (IL-10) levels in gingival crevicular fluid will be evaluated to assess anti-inflammatory response.
Measured: Baseline, 1. month and 3. months
Secondary outcomes (5)
Change in Probing Pocket Depth
Changes in probing pocket depth (PPD) measured in millimeters (mm) will be evaluated.
Measured: Baseline, 1. month and 3. months
Change in Plaque Index
Changes in plaque index scores will be evaluated.
Measured: Baseline, 1. month and 3. months
Change in Gingival Index
Changes in gingival index scores will be evaluated.
Measured: Baseline, 1. month and 3. months
Change in Bleeding on Probing
Changes in bleeding on probing (BOP), expressed as the percentage of bleeding sites (%), will be evaluated as an indicator of gingival inflammation.
Measured: Baseline, 1 month and 3 months
Change in Clinical Attachment Level
Changes in clinical attachment level (CAL) measured in millimeters (mm) will be evaluated.
Measured: Baseline, 1. month and 3. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start9 Apr 2025
- Primary completion28 Apr 2026
- Study completion30 Jun 2026
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.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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 three-arm, randomized, parallel-group clinical trial evaluating non-surgical periodontal therapy alone versus adjunctive hyaluronic acid gel or albumin platelet-rich fibrin (Alb-PRF) in patients with Stage III periodontitis
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Kuşoğlu, Inonu University
- Investigators
- Furkan Kuşoğlu, Principal investigator, Inonu University, Department of Periodontology Faculty of DentistryArife Sabancı, Dr, Study chair, Inonu University, Department of Periodontology Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415148
- Sponsor's protocol ID
- TSA-2024-179
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This study is conducted as a academic thesis and includes sensitive clinical and biochemical data derived from gingival crevicular fluid samples. Although data will be analyzed and reported in aggregate form, sharing individual-level data may compromise participant confidentiality. In addition, institutional and national regulations restrict data sharing without additional ethics approval and explicit participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Hyaluronic Acid and Albumin-PRF as Adjuncts to Non-Surgical Periodontal Treatment on Clinical and Biochemical Parameters
- ClinicalTrials.gov ID
- NCT07415148
- Acronym / sponsor ID
- TSA-2024-179
- Conditions
- Periodontitis, Periodontal Inflammation
- Keywords
- Periodontal Disease, Hyaluronic Acid, Albumin Platelet-Rich Fibrin, Scaling and Root Planing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Feb 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 a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes.
The aim of this randomized clinical trial is to evaluate the effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) used as adjuncts to non-surgical periodontal treatment on clinical and biochemical parameters in patients with Stage III periodontitis. Participants will be randomly allocated into three groups: an Alb-PRF group, a hyaluronic acid gel group, and a control group receiving non-surgical periodontal treatment alone. Clinical periodontal parameters and biochemical markers obtained from gingival crevicular fluid will be assessed at baseline and at 1 and 3 months after treatment. The findings of this study are expected to contribute to the evaluation of the potential benefits of adjunctive biological and anti-inflammatory applications in the non-surgical periodontal treatment of patients with Stage III periodontitis.v
Detailed description
This study is designed as a randomized, parallel-group clinical trial conducted in patients diagnosed with Stage III periodontitis. The aim of the study is to evaluate the adjunctive effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) when used in addition to non-surgical periodontal treatment.
A total of 51 systemically healthy volunteers will be included in the study. Participants will be randomly allocated into three groups (17 patient per group). At the initial visit, all participants will undergo clinical periodontal examination, intraoral photography, and gingival crevicular fluid sampling. Supragingival scaling will be performed for all patients at baseline. One week later, full-mouth scaling and root planing will be completed in a single session.
In the Alb-PRF group, albumin platelet-rich fibrin will be applied as an adjunctive therapy. In the hyaluronic acid group, hyaluronic acid gel will be applied following scaling and root planing and the application will be repeated at the second week. The control group will receive non-surgical periodontal treatment alone without any adjunctive application. Adjunctive treatments will be applied subgingivally immediately after periodontal therapy and one week later.
To evaluate clinical and biochemical outcomes, clinical periodontal parameters and gingival crevicular fluid samples will be collected at baseline and at 1 and 3 months after treatment. Gingival crevicular fluid samples will be obtained using sterile paper strips as a non-invasive method. All collected data will be evaluated at the end of the study. The results of this study are expected to provide additional evidence regarding the effectiveness of adjunctive biological and anti-inflammatory approaches in the non-surgical treatment of Stage III periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-arm, randomized, parallel-group clinical trial evaluating non-surgical periodontal therapy alone versus adjunctive hyaluronic acid gel or albumin platelet-rich fibrin (Alb-PRF) in patients with Stage III periodontitis
| Arm | Type | Receives |
|---|---|---|
| Alb-PRF | Experimental | Procedure: Non-Surgical Periodontal Treatment, Other: Albumin Platelet-Rich Fibrin (Alb-PRF)Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF). |
| Hyaluronic Acid | Experimental | Procedure: Non-Surgical Periodontal Treatment, Other: Hyaluronic Acid GelParticipants receive non-surgical periodontal treatment with adjunctive hyaluronic acid gel application. |
| Control Group | Active comparator | Procedure: Non-Surgical Periodontal TreatmentParticipants receive non-surgical periodontal treatment alone without any adjunctive application. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Systemically healthy individuals aged between 30 and 60 years
- No history of periodontal treatment or antibiotic use within the last 6 months
- Non-smokers
- Accepting to regularly attend the follow-up sessions planned during the study period
- Diagnosis of Stage III periodontitis
Key exclusion criteria (8 listed)
- Presence of any systemic disease
- History of periodontal treatment or antibiotic use within the last 6 months
- Pregnancy or lactation
- Presence of acute oral lesions or necrotizing ulcerative periodontitis
- Use of medications known to affect periodontal tissues
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 |
|---|---|---|
| Non-Surgical Periodontal TreatmentAlso: Scaling and Root PlaningSupragingival scaling was performed at baseline. One week later, full-mouth scaling and root planing were completed in a single session using standard periodontal instruments. | Procedure or surgery | Alb-PRF, Control Group, Hyaluronic Acid |
| Albumin Platelet-Rich Fibrin (Alb-PRF)Albumin platelet-rich fibrin (Alb-PRF) was applied subgingivally as an adjunctive therapy immediately after non-surgical periodontal treatment, with a second application performed one week later. | Other | Alb-PRF |
| Hyaluronic Acid GelAlso: Hyaluronic acid (HA), HA gelHyaluronic acid gel was applied subgingivally as an adjunct to non-surgical periodontal treatment immediately after the procedure, with a second application performed one week later. | Other | Hyaluronic Acid |
Primary outcome
Change in Gingival Crevicular Fluid VEGF Levels
Time frame: Baseline, 1. month and 3. months
Changes in vascular endothelial growth factor (VEGF) levels in gingival crevicular fluid will be analyzed to evaluate angiogenic activity.
Change in Gingival Crevicular Fluid IL-1 Beta Levels
Time frame: Baseline, 1. month and 3. months
Changes in interleukin-1 beta (IL-1β) levels in gingival crevicular fluid will be assessed as a marker of inflammation.
Change in Gingival Crevicular Fluid IL-10 Levels
Time frame: Baseline, 1. month and 3. months
Changes in interleukin-10 (IL-10) levels in gingival crevicular fluid will be evaluated to assess anti-inflammatory response.
5 secondary outcomes
Change in Probing Pocket Depth
Time frame: Baseline, 1. month and 3. months
Change in Plaque Index
Time frame: Baseline, 1. month and 3. months
Change in Gingival Index
Time frame: Baseline, 1. month and 3. months
Change in Bleeding on Probing
Time frame: Baseline, 1 month and 3 months
Change in Clinical Attachment Level
Time frame: Baseline, 1. month and 3. months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This study is conducted as a academic thesis and includes sensitive clinical and biochemical data derived from gingival crevicular fluid samples. Although data will be analyzed and reported in aggregate form, sharing individual-level data may compromise participant confidentiality. In addition, institutional and national regulations restrict data sharing without additional ethics approval and explicit participant consent.
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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. This study is not recruiting at the moment.
Furkan Kuşoğlu principal investigator
Inonu University, Department of Periodontology Faculty of Dentistry
Arife Sabancı, Dr study chair
Inonu University, Department of Periodontology Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Treatment, Albumin Platelet-Rich Fibrin (Alb-PRF) and Hyaluronic Acid Gel in people with Periodontitis and Periodontal Inflammation, run by Inonu University at 1 site 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Crevicular Fluid VEGF Levels (time frame: Baseline, 1. month and 3. months). The study lists 3 primary outcomes in all. 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 7 Jul 2026.