CompletedNot Applicable

Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

Brazil35 participantsStarted 2025-05-11

Plain-language summary

To evaluate the impact of Pulsed Electromagnetic Field (PEMF) on mucositis induced in humans around dental implants and correlate these possible effects with the proteomic profile of implants with and without PEMF and teeth. The hypothesis is that PEMF may modulate bacterial biofilm formation around dental implants and enhance the host response following plaque-induced peri-implant mucositis. Secondary analysis will be the increase in the soft tissue volume using Intra-oral scanning (IOS).

Who can participate

Age range

18 Years – 60 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: -healthy individuals over 18 years of age * have at least 2 contiguous edentulous spaces * more than 15 teeth * have not undergone periodontal treatment for at least 6 months before the start of the study Exclusion Criteria: - Individuals with extensive dental restorations; * with periodontal disease stages II to IV * with peri-implantitis and/or mucositis (Shibli et al. 2015); * individuals requiring previous grafting for implant insertion; * diabetics; * smokers or former smokers; * pregnant women; lactating women; * use of antibiotics or oral antiseptics in the last 6 months .

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

Number of clusters of microorganism

Timeframe: time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days

Trial details

NCT IDNCT07045636

SponsorJamil awad shibli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-11

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