Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithel… (NCT03554876) | Clinical Trial Compass
CompletedNot Applicable
Randomized and Controlled Clinical Trial to Evaluate Bacterial Adhesion on Multi-Im® Transepithelial Components
Spain17 participantsStarted 2018-07-16
Plain-language summary
This study evaluates the efficacy of Mutli-Im® transepithelial components in the inhibition of bacterial adhesion.
The control group will be the Multi-Im® transepithelial component with the conventional surface (Multi-IM® Machined) and the experimental group will be the Multi-Im transepithelial components with the Ti-Golden® surface (Multi-Im Golden) or with the nanogolden surface (Multi-Im® nanogolden). Periodontal indices and biofilformation will be assessed during 2 months after implant loading. Metagenomic analysis and PCR technique will be implemented to assess the biofilm formation.
Who can participate
Age range
18 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:
* Indication of having to place at least three dental implants.
* Plate index ≤ 20% and absence of evidence of active periodontal disease.
* Bleeding index of adjacent teeth ≤ 30%.
* Probing depth in adjacent teeth \<4 mm.
* Not having used systemic antibiotics during the last 6 months.
* Non smoker.
* Possibility for observation during the treatment period.
* Having signed the informed consent.
Exclusion Criteria:
* Suffering any alteration or serious hematologic disease.
* Being undergoing or having received in the 30 days prior to inclusion:
radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants.
* Presence of malignant tumors, hemangiomas or angiomas in the area of implant placement.
* Patients undergoing treatment with bisphosphonate drugs, both orally and intravenously.
* Metabolic bone disease.
* Diseases that affect the oral mucosa.
* Diabetic patients.
* Severe parafunctional habits and/or temporomandibular joint disorders.
* Pregnant or lactating women.
* Physical or mental inability to maintain a good oral hygiene.
* Being participating in another study.
* In general, any inability to participate in the study.
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
Total amount of the 25 most relevant bacterial species in peri-implantitis processes measured in the retired Multi-Im implants
Timeframe: 24 hours
2
Total amount of the 25 most relevant bacterial species in peri-implantitis processes