Recruiting NCT04276246
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dental implants and retentive implant components, dental implants and supportive implant components.
- Who it may be relevant to
- Registry conditions: Partial Edentulism Kennedy Class 1. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
Overview
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
Interventions
- Device dental implants and retentive implant components
retentive components (Group A Test), which are connected to the implants to retain the RPD - Device dental implants and supportive implant components
supportive components (Group B Control), which are connected to the implants to support the RPD
Primary outcome measures
- Changes in patient-reported outcome measures (PROM) [Time frame: 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)]
- Changes in chewing efficiency [Time frame: 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 outcome measures (3)
- prosthetic and implant survival rates [Time frame: during follow-ups, 1 of 5 years after implant placement]
- cost-benefit-analyses [Time frame: during follow-ups, 1 of 5 years after implant placement]
- Evaluation of success of entire treatment [Time frame: during follow-ups, 1 of 5 years after implant placement]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Switzerland · 1 center
- Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, U — Basel
Identifiers
NCT: NCT04276246 · 2019-02167; ex19Joda2