Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage (NCT04328051) | Clinical Trial Compass
UnknownNot Applicable
Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage
Spain105 participantsStarted 2018-06-13
Plain-language summary
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
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:
* Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
* ≥18-years-old patients.
* Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
* Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
* O'Leary plaque index and or bleeding on probing ≤25%.
* Dental implants with screwed-retained prosthesis.
Exclusion Criteria:
* Systemic diseases that can interfere dental implant placement.
* Any contraindication for surgery procedures.
* Heavy smokers (\> 20cig/day).
* Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
* Patients who have had participated with another clinical trial the last 30 days.
* Pregnant women or in lactation.
* Patients with bad oral hygiene or not motivated.
* Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
* Guided bone regeneration required in the same time of the implant placement.
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
Change in Vertical Marginal Bone Loss (VMBL)
Timeframe: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.