- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415148
Hyaluronic Acid and Albumin-PRF in Non-Surgical Periodontal Therapy
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
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi
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Malatya, Battalgazi, Turkey (Türkiye), 44280
- Inonu University Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Alb-PRF
Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF).
|
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:
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.
|
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:
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:
|
|
Active Comparator: Control Group
Participants receive non-surgical periodontal treatment alone without any adjunctive application.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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.
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Baseline, 1. month and 3. months
|
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Change in Gingival Crevicular Fluid IL-1 Beta Levels
Time Frame: Baseline, 1. month and 3. months
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Changes in interleukin-1 beta (IL-1β) levels in gingival crevicular fluid will be assessed as a marker of inflammation.
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Baseline, 1. month and 3. months
|
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Change in Gingival Crevicular Fluid IL-10 Levels
Time Frame: Baseline, 1. month and 3. months
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Changes in interleukin-10 (IL-10) levels in gingival crevicular fluid will be evaluated to assess anti-inflammatory response.
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Baseline, 1. month and 3. months
|
Secondary Outcome Measures
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
|
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Change in Plaque Index
Time Frame: Baseline, 1. month and 3. months
|
Changes in plaque index scores will be evaluated.
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Baseline, 1. month and 3. months
|
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Change in Gingival Index
Time Frame: Baseline, 1. month and 3. months
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Changes in gingival index scores will be evaluated.
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Baseline, 1. month and 3. months
|
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Change in Bleeding on Probing
Time Frame: Baseline, 1 month and 3 months
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Changes in bleeding on probing (BOP), expressed as the percentage of bleeding sites (%), will be evaluated as an indicator of gingival inflammation.
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Baseline, 1 month and 3 months
|
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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
Sponsor
Investigators
- 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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Periodontitis
- Periodontal Diseases
- Carbohydrates
- Glycosaminoglycans
- Polysaccharides
- Digestive System and Oral Physiological Phenomena
- Dentistry
- Dental Physiological Phenomena
- Dental Scaling
- Dental Prophylaxis
- Periodontics
- Subgingival Curettage
- Preventive Dentistry
- Hyaluronic Acid
- Root Planing
- Tooth Exfoliation
Other Study ID Numbers
- TSA-2024-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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