An interventional study of Minimally Invasive Non-Surgical Periodontal Therapy (MINST) and 5% Melatonin Gel in Periodontitis and Diabete Mellitus, sponsored by Badr University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Badr University · Not applicable, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 32 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Badr University is the lead sponsor of 64 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with higher than 6.5% were defined as diabetic.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 involving subgingival instrumentation using appropriate periodontal instruments under magnification loupes, with the aim of preserving soft tissue integrity and minimizing treatment trauma.
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).
Clinical Attachment Level (CAL)
Change in clinical attachment level (CAL) from baseline to follow-up (measured in mm) following minimally invasive non-surgical periodontal therapy (MINST) with or without adjunctive local application of 5% melatonin gel.
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
Probing Pocket Depth (PPD)
Change in probing pocket depth from baseline to follow-up (measured in mm)
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
Full mouth plaque score (FMPS)
Percentage of the sites of plaque
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
Full mouth bleeding score (FMBS)
Percentage of the sites of bleeding
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
GCF Galectin-3
Change in Gingival crevicular fluid level of human galactic-3
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
GCF Interleukin 1
Change in Gingival crevicular fluid level of human interleukin 1
Time frame: from enrollment to 4 weeks then to the end of the study at 8 weeks
Serum glycemic level
Assessment of patient's level of glycemic control measured by hba1c test
Time frame: from enrollment to the end of the study at 8 weeks
Patient satisfaction
Assessment of Patient satisfaction by Likert-scale questionnaire
Time frame: 8 weeks
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 4 months is below that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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