Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant (NCT05016401) | Clinical Trial Compass
CompletedNot Applicable
Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
France199 participantsStarted 2020-11-06
Plain-language summary
As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.
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:
* Edentulous patient requiring the placement of one (or more) dental implant (s) in the maxilla or mandibular
* Age ≥ 18 years old
* Good general health (ASA score between \[1-2\])
* Sufficient volume and bone quality (with or without bone graft) to support the implant
* Non-objection of the patient for the collection of his medical data as part of the study
Exclusion Criteria:
* Poor oral hygiene
* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
* Infections and oral inflammation such as active periodontitis, active gingivitis
* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
* Heavy smoker (\> 10 cigarettes / day)
* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
* Patient on prolonged steroid therapy
* Titanium / titanium alloy allergy
* Alcohol or drug abuse
* Pregnant woman (or likely to be pregnant); or breastfeeding
* Difficulty of medical follow-up patients with geographical, social or psychological constraints
* Persons deprived of liberty or guardianship
* Involuntary / patient refusal 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.