Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I (NCT04276246) | Clinical Trial Compass
RecruitingNot Applicable
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
Switzerland12 participantsStarted 2020-02-06
Plain-language summary
In this study the additional effect of supplementary implants in patients with Kennedy Class I in terms of patient-reported outcome measures (PROMs) and cost-benefit-analyses comparing costs of maintenance care will be investigated
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 must have voluntarily signed the informed consent before any study action, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Males and females with at least 18 years of age
* intraoral situation with bilateral edentulous areas located posterior to the remaining natural teeth (Kennedy class I) in the upper or lower jaw
* remaining dentition includes a first premolar, canine or incisor as the most posterior tooth
Exclusion Criteria:
* Uncontrolled systemic disease that would interfere with dental implant therapy;
* Patients who smoke \> 10 cigarettes per day or tobacco equivalents;
* Patients with alcohol and/or drug abuse;
* Patients with chronic pain;
* Patients with untreated periodontitis and / or inadequate oral hygiene (Plaque Index \< 30%);
* Medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment;
* Conditions or circumstances, in the opinion of the investigators, which would prevent completion of study participation or interfere with analysis of study results such as history of non-compliance or unreliability.
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
Changes in patient-reported outcome measures (PROM)
Timeframe: assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)
2
Changes in chewing efficiency
Timeframe: assessment before implant placement, -1 week and 3 months after RPD insertion, 1 week and 3 months after connecting the implant components, 1 to 5 years after implant placement (5-year study period)