A Clinical Study Collecting Patients' Experience During Dental Implant Treatment (NCT06673563) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study Collecting Patients' Experience During Dental Implant Treatment
99 participantsStarted 2025-01
Plain-language summary
The study will gather data on patient reported experience (PREM) before, during and after dental implant treatment. Patients scheduled in three treatment groups for either single tooth, multiple teeth or full-arch dental rehabilitation are included in the study and will be treated according standard of care. Additionally, they are asked to report their experience based on pre-defined questionnaire assessing patient acceptance of implant treatment in dentistry. Patients will be followed-up until 1-Year post Final Prosthesis Delivery.
This studies primary endpoint is the completion of the PREM questionnaires. The study is not intended to investigate safety and performance of the used medical devices.
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:
* Subject signed informed consent
* Subject is at least 18 years old at the time of treatment
* Subject presented with the need of dental implant treatment for single tooth, multiple teeth, or full-arch rehabilitation
* Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU)
* Subject agree to provide information on her/his experience and outcomes before, during and after the treatment
* Subject has a working e-mail address
* Subject has sufficient English language skills for answering the PREM questionnaires
Exclusion Criteria:
* Anatomical conditions discovered during surgery preventing the use of intended implant system
* Subject with history of allergy or adverse reactions to any materials used
* Uncontrolled unstable systemic disease
* Any ongoing application of medication that is interfering with the dental treatment
* Subject is not willing / unable to complete the PREM questionnaires
* Subject that is planning not to return to the investigational site for follow-up visits within study schedule
* Pregnant or lactating women at the time of implant insertion
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
Patient reported experience at Pre-Treatment, Baseline (Implant Insertion) and Up to 6 months (Final Prosthesis Delivery)
Timeframe: Pre-Treatment, Baseline (Implant Insertion), Up to 6 months (Final Prosthesis Delivery)