Hyaluronic Acid and Albumin-PRF in Non-Surgical Periodontal Therapy

March 23, 2026 updated by: Furkan Kuşoğlu, Inonu University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Battalgazi
      • Malatya, Battalgazi, Turkey (Türkiye), 44280
        • Inonu University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alb-PRF
Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF).
Procedure: Non-Surgical Periodontal Treatment
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.
Other Names:
  • Scaling and Root Planing
Other: 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.
Experimental: Hyaluronic Acid
Participants receive non-surgical periodontal treatment with adjunctive hyaluronic acid gel application.
Procedure: Non-Surgical Periodontal Treatment
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.
Other Names:
  • Scaling and Root Planing
Other: Hyaluronic Acid 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.
Other Names:
  • HA gel
  • Hyaluronic acid (HA)
Active Comparator: Control Group
Participants receive non-surgical periodontal treatment alone without any adjunctive application.
Procedure: Non-Surgical Periodontal Treatment
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.
Other Names:
  • Scaling and Root Planing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1. month and 3. months
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.
Baseline, 1. month and 3. months
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.
Baseline, 1. month and 3. months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth
Time Frame: Baseline, 1. month and 3. months
Changes in probing pocket depth (PPD) measured in millimeters (mm) will be evaluated.
Baseline, 1. month and 3. months
Change in Plaque Index
Time Frame: Baseline, 1. month and 3. months
Changes in plaque index scores will be evaluated.
Baseline, 1. month and 3. months
Change in Gingival Index
Time Frame: Baseline, 1. month and 3. months
Changes in gingival index scores will be evaluated.
Baseline, 1. month and 3. months
Change in Bleeding on Probing
Time Frame: Baseline, 1 month and 3 months
Changes in bleeding on probing (BOP), expressed as the percentage of bleeding sites (%), will be evaluated as an indicator of gingival inflammation.
Baseline, 1 month and 3 months
Change in Clinical Attachment Level
Time Frame: Baseline, 1. month and 3. months
Changes in clinical attachment level (CAL) measured in millimeters (mm) will be evaluated.
Baseline, 1. month and 3. months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Furkan Kuşoğlu, Inonu University, Department of Periodontology Faculty of Dentistry
  • Study Chair: Arife Sabancı, Dr, Inonu University, Department of Periodontology Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSA-2024-179

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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