Clinical Trial: Single-implant Overdentures Retained by the Novaloc Attachment System

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: McGill University

Current Primary Outcome: Denture satisfaction [ Time Frame: 18 months ]

To be assessed by specific questionnaires


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: McGill University

Dates:
Date Received: April 13, 2017
Date Started: May 1, 2017
Date Completion: December 20, 2020
Last Updated: April 24, 2017
Last Verified: April 2017