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

NCT07415148 | Active Not Recruiting

• 1 other identifier: TSA-2024-179
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Periodontitis; Periodontal Inflammation

Keywords

Periodontal Disease; Hyaluronic Acid; Albumin Platelet-Rich Fibrin; Scaling and Root Planing

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 1. month and 3. months

Secondary Outcomes (5)

• Change in Probing Pocket Depth

  Baseline, 1. month and 3. months

• Change in Plaque Index

  Baseline, 1. month and 3. months

• Change in Gingival Index

  Baseline, 1. month and 3. months

• Change in Bleeding on Probing

  Baseline, 1 month and 3 months

• Change in Clinical Attachment Level

  Baseline, 1. month and 3. months

Study Arms (3)

Alb-PRF

EXPERIMENTAL

Participants receive non-surgical periodontal treatment with adjunctive application of albumin platelet-rich fibrin (Alb-PRF).

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.

Procedure: Non-Surgical Periodontal Treatment; Other: Hyaluronic Acid Gel

Control Group

ACTIVE COMPARATOR

Participants receive non-surgical periodontal treatment alone without any adjunctive application.

Procedure: Non-Surgical Periodontal Treatment

Interventions

Hyaluronic Acid Gel OTHER

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.

Also known as: Hyaluronic acid (HA), HA gel

Hyaluronic Acid

Non-Surgical Periodontal Treatment PROCEDURE

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.

Also known as: Scaling and Root Planing

Alb-PRF; Control Group; Hyaluronic Acid

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.

Alb-PRF

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Furkan Kuşoğlu

  Inonu University, Department of Periodontology Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Arife Sabancı, Dr

  Inonu University, Department of Periodontology Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: April 9, 2025
• Primary Completion: April 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)