Single-implant Overdentures Retained by the Novaloc Attachment System
- Conditions
- Edentulous MouthEdentulous Jaw
- Interventions
- Device: NovalocDevice: Locator
- Registration Number
- NCT03126942
- Lead Sponsor
- McGill University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Locator, then Novaloc 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 Locator, then Novaloc Locator 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 Novaloc, then Locator 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 Novaloc, then Locator Novaloc 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
- Primary Outcome Measures
Name Time Method Denture satisfaction 18 months To be assessed by specific questionnaires
- Secondary Outcome Measures
Name Time Method Plaque Index 18 months Presence of plaque according to Silness \& Loe (Acta Odont Scand 1963;21:533-51) (ordinal scale ranging from 0 to 3)
Overdenture rotation 18 months Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43)
Presence of calculus 18 months Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3)
Bleeding on probing 18 months Bleeding on probing around implant (yes/no)
Oral health-related quality of life 18 months To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire
Peri-implant probing depth 18 months Depth of peri-implant pockets (in mm)
Mucosal inflammation 18 months Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change)
Success/survival rate 18 months Success/survival rate of prostheses and implants (yes/no)
Treatment costs 18 months Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses
Trial Locations
- Locations (1)
McGill University, Faculty of Dentistry
🇨🇦Montreal, Quebec, Canada