Single-implant Overdentures Retained by the Novaloc Attachment System: Study Protocol for a Mixed Methods Randomized Cross-over Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McGill University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Denture satisfaction
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Novaloc, then Locator
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
Intervention: Novaloc (Device)
Novaloc, then Locator
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
Intervention: Locator (Device)
Locator, then Novaloc
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
Intervention: Novaloc (Device)
Locator, then Novaloc
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
Intervention: Locator (Device)
Outcomes
Primary Outcomes
Denture satisfaction
Time Frame: 18 months
To be assessed by specific questionnaires
Secondary Outcomes
- Overdenture rotation(18 months)
- Success/survival rate(18 months)
- Plaque Index(18 months)
- Presence of calculus(18 months)
- Bleeding on probing(18 months)
- Oral health-related quality of life(18 months)
- Peri-implant probing depth(18 months)
- Mucosal inflammation(18 months)
- Treatment costs(18 months)