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NCT07631273
Adjunctive Hyaluronic Acid Gel in Non-Surgical Periodontal Treatment of Patients With Diabetes Mellitus
Conditions: Periodontitis, Diabetes Mellitus, Hyaluronic Acid, Oral Microbiota, IL-34, β-CTX
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 23
Sponsor: Marmara University
Location: Department of Periodontology, Faculty of Dentistry, Marmara University Istanbul
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07631273). StuddyBuddy aggregates publicly available trial information.