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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
McGill University, Faculty of Dentistry
Montreal, Quebec, Canada
Denture satisfaction
To be assessed by specific questionnaires
Time frame: 18 months
Oral health-related quality of life
To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire
Time frame: 18 months
Overdenture rotation
Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43)
Time frame: 18 months
Success/survival rate
Success/survival rate of prostheses and implants (yes/no)
Time frame: 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)
Time frame: 18 months
Presence of calculus
Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3)
Time frame: 18 months
Peri-implant probing depth
Depth of peri-implant pockets (in mm)
Time frame: 18 months
Bleeding on probing
Bleeding on probing around implant (yes/no)
Time frame: 18 months
Mucosal inflammation
Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change)
Time frame: 18 months
Treatment costs
Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses
Time frame: 18 months
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