A Phase 2 interventional study of Melatonin gel and Minimally Invasive Non-Surgical Therapy (MINST) in Periodontitis, Periodontitis (Stage 3) and Periodontitis Stage IV, sponsored by Badr University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Badr University · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to learn if adding melatonin gel to standard deep cleaning of the gums improves healing in adults with Stage III or IV periodontitis (advanced gum disease).
The main questions it aims to answer are:
Researchers will compare deep cleaning plus melatonin gel to deep cleaning alone to see if melatonin gel gives better results.
Participants will:
Periodontitis is a chronic inflammatory disease driven by a dysbiotic microbial biofilm and an exaggerated host immune-inflammatory response, leading to destruction of the tooth-supporting tissues. Non-surgical periodontal therapy remains the cornerstone of treatment; however, its outcomes may be limited in advanced (Stage III-IV) cases, which has led to growing interest in local host-modulating adjuncts.
Melatonin is an endogenous indoleamine with antioxidant, anti-inflammatory, immunomodulatory, and bone-protective properties. Reduced salivary and gingival crevicular fluid (GCF) melatonin levels have been reported in patients with periodontitis, supporting its potential role as a local adjunct to non-surgical therapy.
Galectin-3 is a beta-galactoside-binding lectin involved in inflammation, immune cell regulation, and tissue remodeling, while interleukin-1 (IL-1) is a key pro-inflammatory cytokine associated with periodontal tissue breakdown. Measuring both markers in GCF allows evaluation of the biological response to treatment.
This randomized controlled clinical trial will include 40 patients with Stage III-IV periodontitis, randomly allocated into two equal groups (n = 20 each):
Primary outcome: clinical attachment level (CAL). Secondary outcomes: probing pocket depth (PPD), full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), gingival recession (GR), patient satisfaction, and GCF levels of Galectin-3 and IL-1 measured by ELISA.
Clinical parameters and GCF samples will be collected at baseline, 1 month, and 2 months after treatment.
The study is conducted at the Faculty of Oral and Dental Medicine, Badr University in Cairo, Egypt, as part of a Master's degree in Periodontology
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 40 is close to 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.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Stage III-IV periodontitis will receive minimally invasive non-surgical periodontal therapy (MINST) followed by intra-pocket application of melatonin gel once weekly for 4 weeks
Drug: Melatonin gel · Procedure: Minimally Invasive Non-Surgical Therapy (MINST)
Patients with Stage III-IV periodontitis will receive minimally invasive non-surgical periodontal therapy (MINST) only.
Procedure: Minimally Invasive Non-Surgical Therapy (MINST)
Intra-pocket application of melatonin gel once weekly for 4 weeks following MINST.
Minimally invasive non-surgical periodontal therapy using mini-curettes and ultrasonic mini-tips under magnification.
Clinical Attachment Level (CAL)
CAL will be measured in millimeters from the cemento-enamel junction to the base of the periodontal pocket using a UNC-15 periodontal probe at six sites per tooth.
Time frame: Baseline, 1 month, and 2 months after treatment
Probing Pocket Depth (PPD)
PPD will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at six sites per tooth.
Time frame: Baseline, 1 month, and 2 months after treatment
Full-Mouth Plaque Score (FMPS)
Percentage of tooth surfaces with plaque, recorded at four sites per tooth.
Time frame: Baseline, 1 month, and 2 months after treatment
Full-Mouth Bleeding Score (FMBS)
Percentage of sites with bleeding on probing, recorded at six sites per tooth.
Time frame: Baseline, 1 month, and 2 months after treatment
Gingival Recession (GR)
Measured in millimeters from the cemento-enamel junction to the gingival margin using a UNC-15 periodontal probe.
Time frame: Baseline, 1 month, and 2 months after treatment
Gingival Crevicular Fluid Galectin-3 Level
Concentration of Galectin-3 in gingival crevicular fluid measured by ELISA (ng/mL).
Time frame: Baseline, 1 month, and 2 months after treatment
Gingival Crevicular Fluid Interleukin-1 (IL-1) Level
Concentration of IL-1 in gingival crevicular fluid measured by ELISA (pg/mL).
Time frame: Baseline, 1 month, and 2 months after treatment
Patient Satisfaction
Assessed using a visual analogue scale (VAS) questionnaire.
Time frame: 2 months after treatment
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly to protect participant confidentiality. De-identified data may be made available from the principal investigator upon reasonable request, subject to approval by the Research Ethics Committee of the Faculty of Oral and Dental Medicine, Badr University in Cairo
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2027, 2 months later.
Of 18 phase 2 interventional studies 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 21. This study's planned 2 months is below that.
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 Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
Badr University