Single-implant Overdentures Retained by the Novaloc Attachment System

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03126942
Study type	Interventional
Source	McGill University
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2018
Completion date	March 8, 2021

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