Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Study Overview
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Brief Summary
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Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture. In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture. Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.

Official Title
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Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial

Conditions
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Edentulous

Intervention / Treatment
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* Procedure: Denture implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'. They have to be willing to commit to 1.5 year of participation in the study. They have to be edentulous for at least one year before starting the implant procedure. Exclusion Criteria: Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates) History of radiotherapy in the head and neck region Insufficient bone for an implant of at least 10 mm length and 4 mm diameter Previously treated with dental implants

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly with an unstable mandibular denture.<br> | Procedure: Denture implantation<br>* In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture. Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments. The total duration of the study will be 12 to 18 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction after insertion of the new complete dentures. | This will be measured by a questionnaire with 20 items. | 1 week after insertion of the new complete dentures. | 
| Patient satisfaction after insertion of the complete dentures. | This will be measured by a questionnaire with 20 items. | 8 weeks after insertion of the complete dentures. | 
| Patient satisfaction post-surgical. | This will be measured by a questionnaire with 20 items. | 1 week post-surgical. | 
| Patient satisfaction after surgical procedure, functional loading. | This will be measured by a questionnaire with 20 items. | 6-8 weeks after surgical procedure. | 
| Patient satisfaction after loading the implant. | This will be measured by a questionnaire with 20 items. | 1 week after loading the implant. | 
| Patient satisfaction after loading. | This will be measured by a questionnaire with 20 items. | 1 months after loading. | 
| Patient satisfaction after loading. | This will be measured by a questionnaire with 20 items. | 6 months after loading | 
| Patient satisfaction after loading. | This will be measured by a questionnaire with 20 items. | 1 year after loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant level : lost implants, loose implants, … |  | From the first week post-surgical to 1 year after loading. | 
| Soft tissue level : Peri-implant inflammation, bleeding index, probing depth |  | From the first week post-surgical to 1 year after loading. | 
| Denture related: soft tissue problems. |  | From 1 week after insertion of the new complete dentures to 6 months after loading. | 
| Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number. |  | From 8 weeks after insertion of the complete dentures to 6 months after loading. | 
| Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus. |  | From 1 week after loading the implant to 6 months after loading. | 
| Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi. |  | From 8 weeks after insertion of the complete dentures to 6 months after loading. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single implant denture, Elderly with an unstable mandibular denture