A Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant … (NCT04942808) | Clinical Trial Compass
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A Study of the Crestal Bone Loss Around Bone Level Versus Tissue Level Implants in Non-compliant Patients With Healthy or Reduced Periodontium After 5-8 Years in Function
Lebanon130 participantsStarted 2021-06-01
Plain-language summary
The goal is to evaluate, after 5 to 8 years, the marginal bone loss around tissue-level implants and bone-level implants in patients who have not followed the maintenance program.
Medical records of patients who have been implanted for at least 5 to 8 years and who have been lost during this period are collected from three private clinics in Beirut,Lebanon and the Saint Joseph University Health Center in Beirut,Lebanon.
On an individual sheet, the patient as well as the implants data will be noted. Patients will be called for reevaluation after 5-8 years. After signing the informed consent, the measurements by a PCP-15 probe of the plaque index (FMPS) and the bleeding index (FMBS) as well as the height of the keratinized tissue are indicated on the sheet. If the smoking status has changed, this will be mentioned too.
The marginal bone loss will be measured on the X-rays taken immediately after the implant placement, after 1 year of loading and then at the reevaluation session.
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:
* Patients who have undergone the initial phase followed by implant placement in the posterior region.
* Implants placed for more than 5 years.
* The implant systems selected are:
* Tissue Level Implants: Straumann (Straumann Dental Implants System, Switzerland),
* Bone Level implants: Branemark, 3i Biomet (external and internal connection), Nobel replace and Astra.
* Patients who did not comply with the maintenance program and who missed more than 30% of appointments.
Exclusion Criteria:
* Systemic diseases (uncontrolled diabetes, drugs which may affect bone metabolism).
* Totally edentulous.
* Severe periodontitis not stabilized
* Inappropriate, unavailable or distorted x-rays.
* Augmented sites.
* Implants placed at a supra or infraosseous level.
* Implants placed immediately after extraction.
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.