Clinical trial NCT04276246: Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
Official title: Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partial Edentulism Kennedy Class 1
Keywords: Partial Edentulism
Kennedy Class 1
Removable partial dentures (RPDs)
Supplementary implants
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2020-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: prosthetic and implant survival rates
timeFrame: during follow-ups, 1 of 5 years after implant placement
measure: cost-benefit-analyses
timeFrame: during follow-ups, 1 of 5 years after implant placement
measure: Evaluation of success of entire treatment
timeFrame: during follow-ups, 1 of 5 years after implant placement
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel
Study officials:
References: