- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276246
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
April 12, 2024 updated by: University Hospital, Basel, Switzerland
Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
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
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicola Zitzmann, Prof. Dr.
- Phone Number: +41 61 267 26 31
- Email: n.zitzmann@unibas.ch
Study Contact Backup
- Name: Tim Joda, Prof. Dr.
- Phone Number: +41 61 267 26 31
- Email: tim.joda@unibas.ch
Study Locations
-
-
-
Basel, Switzerland, 4058
- Recruiting
- Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel
-
Contact:
- Nicola Zitzmann, Prof. Dr.
- Phone Number: +41 61 267 26 31
- Email: n.zitzmann@unibas.ch
-
Contact:
- Tim Joda, Prof. Dr.
- Phone Number: +41 61 267 26 31
- Email: tim.joda@unibas.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
All included participants receive each side 1 posterior implant in the edentulous areas bilaterally in Kennedy class I. Participants are provided with a conventional clasp retained removable partial denture (RPD) worn for 3 months.
When implant osseointegration is ensured (3 months healing period), patients are assigned to retentive components (Group A, Test) which are connected to the implants to retain the RPD
|
retentive components (Group A Test), which are connected to the implants to retain the RPD
|
Experimental: Control
All included participants receive each side 1 posterior implant in the edentulous areas bilaterally in Kennedy class I. Participants are provided with a conventional clasp retained removable partial denture (RPD) worn for 3 months.
When implant osseointegration is ensured (3 months healing period), patients are assigned to supportive components (Group B, Control), which are connected to the implants to support the RPD
|
supportive components (Group B Control), which are connected to the implants to support the RPD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
|
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
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
cost-benefit-analyses over time, including costs during maintenance care during follow-up of 5 years will be conducted to compare test and control
|
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
|
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)
|
during follow-ups, 1 of 5 years after implant placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2020
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (Actual)
February 19, 2020
Study Record Updates
Last Update Posted (Actual)
April 15, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-02167; ex19Joda2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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