Not yet recruitingNCT07928752ClinicalTrials.gov record

Effects of Adjunctive Melatonin Gel in Type II Diabetics With Stage III-IV Periodontitis

Periodontitis · Diabete Mellitus

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 32 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this clinical trial is to learn if melatonin gel works to treat deep periodontal pockets in diabetic patients with periodontisits.

The main question it aims to answer is:

Does melatonin gel when used with minimal invasive non surgical periodontal therapy show better healing effects.

Read the full description

The goal of this clinical trial is to evaluate the effects of adjunctive locally delivered Melatonin gel combined with minimally invasive non-surgical therapy (MINST), compared with MINST alone, on clinical periodontal parameters, serum glycemic levels, and gingival crevicular fluid levels of Galectin-3 and interleukin-1β in patients with Stage III/IV periodontitis and type 2 diabetes mellitus.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Male and female participants. Patients diagnosed with Stage III / IV periodontitis. Presence of at least one site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment loss consistent with Stage III/ IV periodontitis.

Subjects with glycated hemoglobin higher than 6.5% were defined as diabetic.

Exclusion Criteria:

Smokers: current or former, as smoking impairs periodontal healing capacity and response to periodontal treatments.

Pregnancy and lactation due to ethical considerations and potential hormonal influences on periodontal tissues.

Patient who received periodontal therapy within the previous 6 months. Use of antibiotics, anti-inflammatory drugs, or antioxidant supplement within the previous 6 months.

Patient with systemic condition other than type 2 diabetes or medication that may affect periodontal healing.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

MINST + Melatonin Gel

Participants will receive minimally invasive non-surgical periodontal therapy (MINST), followed by adjunctive subgingival application of 5% melatonin gel into selected periodontal pockets using a syringe equipped with a suitable cannula, once weekly for four consecutive weeks.

Procedure: Minimally Invasive Non-Surgical Periodontal Therapy (MINST) · Procedure: 5% Melatonin Gel

MINST Alone

Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone, without adjunctive melatonin gel.

Procedure: Minimally Invasive Non-Surgical Periodontal Therapy (MINST)

Minimally Invasive Non-Surgical Periodontal Therapy (MINST) PROCEDURE

Minimally invasive non-surgical periodontal therapy involving subgingival instrumentation using appropriate periodontal instruments under magnification loupes, with the aim of preserving soft tissue integrity and minimizing treatment trauma.

5% Melatonin Gel PROCEDURE

Locally delivered 5% melatonin gel administered by subgingival application into selected periodontal pockets using a syringe equipped with a suitable cannula, The gel will be applied once weekly for four consecutive weeks as an adjunct to minimally invasive non-surgical periodontal therapy (MINST).

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