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The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| c-SIMO | Experimental | Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture. |
|
| m-SIMO | Active Comparator | Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| c-SIMO | Device | Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OHIP-EDENT | Oral health-related quality of life questionnaire | From baseline to 5-year follow-up |
| DSI | Denture Satisfaction Index (questionnaire) | From baseline to 5-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred chewing side | Asymmetry Index | From baseline to 5-year follow-up |
| Chewing efficiency | two-color mixing ability test | From baseline to 5-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Maniewicz | Contact | +4122 379 40 60 | sabrina.maniewicz@unige.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sabrina Maniewicz | University of Geneva, Switzerland | Principal Investigator |
| Frauke Müller | University of Geneva, Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinics of Dental Medicine, University of Geneva | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
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| m-SIMO | Device | Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture. |
|
| Occlusal analysis | Dental Prescale System | From baseline to 5-year follow-up |
| Plaque index | modified Plaque Index (modPI) | From implant loading to 5-year follow-up |
| Bleeding on probing | modified Bleeding Index (modBI) | From implant loading to 5-year follow-up |
| Pocket probing depth | Peri-implant probing depth | From implant loading to 5-year follow-up |
| Keratinized peri-implant tissues | Measurement of the keratinized tissue around implants | From implant loading to 5-year follow-up |
| Prosthodontic assessment | Number of prosthetic complications | From implant loading to 5-year follow-up |
| Peri-implant bone height | Measured on radiographs | From implant loading to 5-year follow-up |