Adjunctive Hyaluronic Acid Gel in Non-Surgical Periodontal Treatment of Patients With Diabetes Mellitus

NCT07631273 | Not Yet Recruiting

• 2 other identifiers: 09.2025.543TDH-2026-12438
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether the adjunctive use of hyaluronic acid (HA) improves periodontal healing in people with diabetes mellitus and periodontitis. The effects of HA on biomolecules and bacteria levels will be assessed during the follow-up period. The main questions the study will answer are:

• Will periodontal sites treated with non-surgical periodontal treatment (NSPT) plus HA gel show better clinical periodontal parameters than sites treated with only NSPT in patients with diabetes and periodontitis?
• will HA gel have additional effect on reducing inflammation or collagen markers, and bacteria levels during follow-up? Researchers will compare periodontal sites receiving NSPT with adjunctive HA gel application to sites receiving NSPT alone to determine whether HA provides additional clinical, biochemical and microbiological benefits. Participants will:
• provide recent HbA1c test results.
• then, the participants will receive full-mouth NSPT then, randomization will be performed for the selected jaw for test sites. These two interproximal test sites will additionally receive HA application.
• attend follow-up visits at 1, 3 and 6 months for clinical periodontal measurements and to provide gingival crevicular fluid samples (GCF) and subgingival samples. The GCF samples will be evaluated for interleukin-34 (IL-34) and beta C-terminal telopeptide (β-CTX) levels and subgingival samples for periodontal pathogens.

Conditions

Periodontitis; Diabetes Mellitus; Oral Microbiota; IL-34; β-CTX; Hyaluronic Acid

Keywords

Periodontitis; diabetes mellitus; Non-surgical Periodontal Treatment; Hyaluronic Acid; Split-mouth Study; IL-34; β-CTX; periodontal pathogens

Outcome Measures

Primary Outcomes (2)

• Change in Clinical Attachment Level

  Clinical attachment level (CAL) will be measured in millimeters using a periodontal probe. The change in CAL will be calculated as the difference between baseline and follow-up measurements. A decrease in CAL indicates an improvement in periodontal attachment.

  Baseline, 1, 3 and 6 months after NSPT

• Change in Probing Depth

  Probing depth will be measured around each tooth by recording the distance in millimeters from the gingival margin to the bottom of the pocket at 6 locations (mesiobuccal, mid-buccal, distobuccal, mesiopalatal, mid-palatal, distopalatal).

  Baseline, 1, 3 and 6 months after NSPT

Secondary Outcomes (10)

• Change of Bleeding on Probing (%)

  Baseline, 1, 3 and 6 months after NSPT

• Change in Plaque Index

  Baseline, 1, 3 and 6 months after NSPT

• Change in Gingival Index

  Baseline, 1, 3 and 6 months after NSPT

• Change in GCF IL-34 Levels

  Baseline, 1, 3 and 6 months after NSPT

• Change in GCF β-CTX Levels

  Baseline to 1, 3 and 6 months after NSPT

Study Arms (2)

Test

ACTIVE COMPARATOR

Non-surgical periodontal treatment and Hyaluronic Acid gel

Procedure: Scaling and root planing; Device: Hyaluronic Acid (HYADENT BG)

Control

OTHER

Non-surgical periodontal treatment alone

Procedure: Scaling and root planing

Interventions

Scaling and root planing PROCEDURE

Scaling and root planing is a conventional gold-standard treatment for periodontitis. As part of this procedure, subgingival plaque and tartar are removed and root surfaces are planed.

Control; Test

Hyaluronic Acid (HYADENT BG) DEVICE

Hyaluronic acid will be locally applied to periodontal pockets as an adjunct to non-surgical periodontal therapy, aiming to support periodontal healing. After completion of scaling and root planing, the material will be delivered subgingivally to designated test sites in a split-mouth design.

Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who sign the informed consent form
• Participants diagnosed with diabetes mellitus (HbA1c %7-7.9)
• Participants without any systemic disease other than DM
• Participants diagnosed with Stage III or Stage IV periodontitis
• Nonsmokers
• Participants with at least 15 natural teeth present in the mouth (excluding third molars)
• Participants in either of the jaws, in both quadrants, having two non-adjacent interproximal sites with probing depth and clinical attachment level ≥6 mm with no caries, restorations or furcation involvement

You may not qualify if:

• Individuals who do not sign the informed consent form
• Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis
• Participants have received any periodontal treatment within 6 months prior to the study
• Participants who have used antibiotics within the last 3 months
• Smokers
• Participants who are pregnant or lactating

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Başak Doğan

CONTACT

+905332621170; basakdogan@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth design

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

TU (1)