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| Name | Class |
|---|---|
| ITI International Team for Implantology, Switzerland | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dental implants and retentive implant components | Device | retentive components (Group A Test), which are connected to the implants to retain the RPD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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 | Description | Time Frame |
|---|---|---|
| prosthetic and implant survival rates | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Zitzmann, Prof. Dr. | Contact | +41 61 267 26 31 | n.zitzmann@unibas.ch | |
| Tim Joda, Prof. Dr. | Contact | +41 61 267 26 31 | tim.joda@unibas.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel | Recruiting | Basel | 4058 | Switzerland |
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| dental implants and supportive implant components | Device | supportive components (Group B Control), which are connected to the implants to support the RPD |
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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 | 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 |
| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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