Increase of Peri-implant Soft Tissues With Screw or Membrane (NCT03358667) | Clinical Trial Compass
CompletedNot Applicable
Increase of Peri-implant Soft Tissues With Screw or Membrane
Italy84 participantsStarted 2017-11-01
Plain-language summary
The objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant.
Who can participate
Age range
19 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
. indications for implant insertion into the posterior mandible based on careful diagnosis and treatment plan;
. presence of a residual bone crest with a minimum surgical height of 7 mm and a thickness of at least 6 mm at the programmed implant sites;
. the bone crest must be cured (at least 6 months after the loss / extraction of the corresponding dental element);
. Soft tissue height above the implant ≤ 2mm;
. no regenerated bone;
. Plaque index below 25% and bleeding index less than 20%;
. buco-lingual amplitude of the adherent gingiva ≥ 4 mm;
. age of the patient\> 18 years;
Exclusion criteria
. acute myocardial infarction in the last 2 months;
. uncompensated coagulation turbines;
. unmanaged diabetes (HbA1c\> 7.5%);
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.