Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-… (NCT05906563) | Clinical Trial Compass
UnknownPhase 2
Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects
Egypt52 participantsStarted 2022-12-14
Plain-language summary
The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.
fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with at least one intra-bony defect diagnosed clinically and radiographically
Exclusion Criteria:
* Patients with systemic diseases.
* Pregnant and lactating females.
* Smokers and tobacco chewers.
* History of antibiotic and periodontal therapy in the last 3 months.
* Patients not compliant with oral hygiene procedures.
* Patients with a known or suspected allergy to the melatonin or metformin.
* Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic assessment
Timeframe: all the parameter will be evaluated after 6 months