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

ConditionsPeriodontitis Diabetes Mellitus Hyaluronic Acid Oral Microbiota IL-34 β-CTX

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Scaling and root planing
Procedure/Surgery
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.

Treatment groups

23 Participants

are divided into 2 treatment groups

Group A: TestActive comparator 2 interventions

Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame