Single-implant Overdentures Retained by the Novaloc Attachment System

Study Overview
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Brief Summary
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The objective of this explanatory mixed methods study is to compare a novel attachment system (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of edentate elders. The investigators will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elders. Participants will be followed for three months with each attachment type; patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with preferred attachment; this latter assessment will enable the observation of attachments' long-term wear and maintenance events.

Official Title
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Single-implant Overdentures Retained by the Novaloc Attachment System: Study Protocol for a Mixed Methods Randomized Cross-over Trial

Conditions
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Edentulous Mouth, Edentulous Jaw

Intervention / Treatment
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* Device: Novaloc
* Device: Locator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not have had a tooth extraction within the past six months Request implant stabilization of a mandibular conventional complete denture Have clinically acceptable maxillary and mandibular complete dentures Have adequate bone in the anterior mandible for the placement of a single 3.3 mm wide implant in the midline Be able to maintain adequate oral hygiene and clean dentures; Present no systemic conditions for which minor oral surgery would be counter-indicated Have an adequate understanding of written and spoken English or French; Be capable of giving written informed consent Exclusion Criteria: Severe/serious illness that requires frequent hospitalization Impaired cognitive function Unable to return for evaluations/study recalls Have a history of radiation therapy to the orofacial region Have specific conditions that may jeopardize the treatment, such as alcoholism or smoking (>10 cigarettes/day) Have acute or chronic symptoms of parafunctional or temporomandibular disorders Previous dental implant treatment Following radiographic exam, investigators will exclude volunteers with bony pathologic lesions, less than 11 mm of minimum vertical mandibular bone height in the midline or width for planned implants, evident endosseous vascular structures or mandibular ridges with remaining alveolar sockets

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novaloc, then Locator<br>Participants will receive the Novaloc attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Locator attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months | Device: Novaloc<br>* Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used<br>Device: Locator<br>* Traditional cylindrical attachment (Locator system) with pink (medium) retentive components<br>|
| Active Comparator: Locator, then Novaloc<br>Participants will receive the Locator attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Novaloc attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months | Device: Novaloc<br>* Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used<br>Device: Locator<br>* Traditional cylindrical attachment (Locator system) with pink (medium) retentive components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denture satisfaction | To be assessed by specific questionnaires | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life | To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire | 18 months | 
| Overdenture rotation | Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43) | 18 months | 
| Success/survival rate | Success/survival rate of prostheses and implants (yes/no) | 18 months | 
| Plaque Index | Presence of plaque according to Silness & Loe (Acta Odont Scand 1963;21:533-51) (ordinal scale ranging from 0 to 3) | 18 months | 
| Presence of calculus | Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3) | 18 months | 
| Peri-implant probing depth | Depth of peri-implant pockets (in mm) | 18 months | 
| Bleeding on probing | Bleeding on probing around implant (yes/no) | 18 months | 
| Mucosal inflammation | Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change) | 18 months | 
| Treatment costs | Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aged patients, Cost Estimates, Complete Denture, Dental Economics, Dental Implants, Dental Prosthesis, Implant-Supported, Denture Retention, Minimally Invasive Surgical Procedures, Oral Health-Related Quality of Life, Overdenture, Patient Acceptance of Health Care, Quality of Healthcare, Quality of Life, Patient Satisfaction, Single implant overdenture