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

Sponsor
Marmara University
Study ID
NCT07631273
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
23 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Test
    Non-surgical periodontal treatment and Hyaluronic Acid gel
  • Other: Control
    Non-surgical periodontal treatment alone

Primary Outcome Measure

Change in Clinical Attachment Level [ Time Frame: Baseline, 1, 3 and 6 months after NSPT ]

Central Contacts

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