Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel
Basel, 4058, Switzerland
Location status: Recruiting
Location contact
Nicola Zitzmann, Prof. Dr.
CONTACT
Tim Joda, Prof. Dr.
CONTACT
Recruiting
NCT Number: NCT04276246
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
dental implants and retentive implant components
Deviceretentive components (Group A Test), which are connected to the implants to retain the RPD
dental implants and supportive implant components
Devicesupportive components (Group B Control), which are connected to the implants to support the RPD
Primary outcomes
-
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)
Assessment of patient's perception of function and oral health comparing conventional RPDs to implant-supported RPDs with and without retentive components in posterior sites of Kennedy Class I. PROMs are evaluated using the Oral Health Impact Profile (OHIP 14), i.e. the short form of OHIP with 14 items measuring oral health-related quality of life (OHQoL). The frequency of impairment in different areas (functional limitation, physical discomfort or disability, psychological discomfort or disability, social disability, and handicap) are indicated on a multi-level scale ("never"=0, "hardly"=1, "sometimes"=2, "often"=3, "very often"=4)
-
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)
Assessment of the chewing Efficiency by masticating standardized fruit gum with three varying degree of hardness. A complete chewing function test comprises 9 chewing sequences: the different hardness of the model food is chewed once on the right, then on the left and finally on both sides. The study participants have 30 seconds for each chewing sequence and 30 seconds between each chewing sequence. Only one fruit gum is chewed per chewing sequence. The samples are placed on a defined area, photographed in standardized manner and analyzed with a computer program. The mean size and amounts of the chewed particles are calculated and determines the chewing efficiency
Secondary outcomes
-
prosthetic and implant survival rates
Time frame: during follow-ups, 1 of 5 years after implant placement
prosthetic and implant survival rates (%) accounting for any technical and biological complication over 5 years
-
cost-benefit-analyses
Time frame: during follow-ups, 1 of 5 years after implant placement
cost-benefit-analyses over time, including costs during maintenance care during follow-up of 5 years will be conducted to compare test and control
-
Evaluation of success of entire treatment
Time frame: during follow-ups, 1 of 5 years after implant placement
evaluation of success of the entire treatment including assessments of technical (prosthesis adjustment or implant abutment adjustment or exchange) and biological complications (peri-implant diseases)
Study contacts
Contact information is provided by the study sponsor or research team.
Nicola Zitzmann, Prof. Dr.
CONTACT
Tim Joda, Prof. Dr.
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Basel, Switzerland
Other
Collaborators
- ITI International Team for Implantology, Switzerland
Registry information
Official study title
Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 19, 2020
- Registry last updated
- May 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.