Partial Edentulism Kennedy Class 1NCT04276246
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I
A study testing dental implants and retentive implant components and dental implants and supportive implant components in people with Partial Edentulism Kennedy Class 1, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism Kennedy Class 1
- What is being tested?
- dental implants and retentive implant components and dental implants and supportive implant components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Feb 2020to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel
Basel, 4058
Nicola Zitzmann, Prof. Dr., +41 61 267 26 31, n.zitzmann@unibas.ch
Tim Joda, Prof. Dr., +41 61 267 26 31, tim.joda@unibas.ch
About this study
Official title: 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
- Conditions
- Partial Edentulism Kennedy Class 1
- Being tested
- dental implants and retentive implant components, dental implants and supportive implant components
- Keywords
- Partial Edentulism, Kennedy Class 1, Removable partial dentures (RPDs), Supplementary implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implants and retentive implant componentsDevice
retentive components (Group A Test), which are connected to the implants to retain the RPD
dental implants and supportive implant componentsDevice
supportive components (Group B Control), which are connected to the implants to support the RPD
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: dental implants and retentive implant components |
| Control | 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 supportive components (Group B, Control), which are connected to the implants to support the RPD Receives: Device: dental implants and supportive implant components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient-reported outcome measures (PROM)
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)
Measured: 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
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
Measured: 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 (3)
prosthetic and implant survival rates
prosthetic and implant survival rates (%) accounting for any technical and biological complication over 5 years
Measured: during follow-ups, 1 of 5 years after implant placement
cost-benefit-analyses
cost-benefit-analyses over time, including costs during maintenance care during follow-up of 5 years will be conducted to compare test and control
Measured: during follow-ups, 1 of 5 years after implant placement
Evaluation of success of entire treatment
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)
Measured: during follow-ups, 1 of 5 years after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start6 Feb 2020
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Edentulism Kennedy Class 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276246
- Sponsor's protocol ID
- 2019-02167; ex19Joda2
- Other IDs
- 2019
- Status last verified
- May 2025
- First submitted
- 6 Feb 2020
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04276246
- Acronym / sponsor ID
- 2019-02167; ex19Joda2
- Conditions
- Partial Edentulism Kennedy Class 1
- Keywords
- Partial Edentulism, Kennedy Class 1, Removable partial dentures (RPDs), Supplementary implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: dental implants and retentive implant componentsAll 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 |
| Control | Experimental | Device: dental implants and supportive implant componentsAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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%);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implants and retentive implant componentsretentive components (Group A Test), which are connected to the implants to retain the RPD | Device | Experimental |
| dental implants and supportive implant componentssupportive components (Group B Control), which are connected to the implants to support the RPD | Device | Control |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
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Bone Loss, Partial Edentulism Class 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implants and retentive implant components and dental implants and supportive implant components in people with Partial Edentulism Kennedy Class 1, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Zitzmann, Prof. Dr. (+41 61 267 26 31, n.zitzmann@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.