Using supplementary implants to support removable dental prostheses for partial edentulism
Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
NA · University Hospital, Basel, Switzerland · NCT04276246
This study tests whether adding extra dental implants can improve the comfort and satisfaction of people with partial tooth loss who use removable dentures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT04276246 on ClinicalTrials.gov |
What this trial studies
This study investigates the additional benefits of supplementary implants in patients with Kennedy Class I partial edentulism. It focuses on patient-reported outcome measures (PROMs) and conducts a cost-benefit analysis comparing the costs of maintenance care. Participants will receive dental implants and retentive components to enhance their removable partial dentures. The study aims to provide insights into the effectiveness and economic implications of this intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with bilateral edentulous areas in the posterior region of the jaw and remaining natural teeth.
Not a fit: Patients with uncontrolled systemic diseases, severe smoking habits, or inadequate oral hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with partial edentulism by enhancing the stability and functionality of their dental prostheses.
How similar studies have performed: Previous studies have shown promising results with supplementary implants in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basel
- Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Nicola Zitzmann, Prof. Dr.
- Email: n.zitzmann@unibas.ch
- Phone: +41 61 267 26 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Partial Edentulism Kennedy Class 1, Partial Edentulism, Kennedy Class 1, Removable partial dentures, Supplementary implants