Journal Article

Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial

Esfandiari, Shahrokh, Bedos, Christophe, Dagdeviren, Didem, Abi Nader, Samer, Makhoul, Nicholas M., Feine, Jocelyne S., Jabbar, Areej A., de Souza, Raphael F.

2018

Overview

Background Overdentures retained by a single implant in the midline have arisen as a minimal implant treatment for edentulous mandibles. The success of this treatment depends on the performance of a single stud attachment that is susceptible to wear-related retention loss. Recently developed biomaterials used in attachments may result in better performance of the overdentures, offering minimal retention loss and greater patient satisfaction. These biomaterials include resistant polymeric matrixes and amorphous diamond-like carbon applied on metallic components. The objective of this explanatory mixed-methods study is to compare Novaloc, a novel attachment system with such characteristics, to a traditional alternative for single implants in the mandible of edentate elderly patients. Methods/design We will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elderly individuals. 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 two 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 the preferred attachment; this latter assessment will enable measurement of the attachments’ long-term wear and maintenance requirements. Discussion Our results will lead to evidence-based recommendations regarding these systems, guiding providers and patients when making decisions on which attachment systems and implant numbers will be most appropriate for individual cases. The recommendation of a specific attachment for elderly edentulous patients may combine positive outcomes from patient perspectives with low cost, good maintenance, and minimal invasiveness. Trial registration ClinicalTrials.gov, NCT03126942 . Registered on 13 April 2017.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Age Factors / Aged / Aged patients / Analysis / Biomedicine / Clinical trials / Complete denture / Complete dentures / Cost reduction / Costs and cost analysis / Cross-Over Studies / Dental care for aged / Dental Care for Aged - instrumentation / Dental Care for Aged - methods / Dental implants / Dental Prosthesis, Implant-Supported / Dentistry / Denture, Overlay / Dentures / Edentulous / Edentulous mouth / Female / Health aspects / Health Sciences / Humans / Hypotheses / Implant-supported dental prosthesis / Jaw, Edentulous - diagnostic imaging / Jaw, Edentulous - surgery / Male / Mandible - diagnostic imaging / Mandible - surgery / Medicine / Medicine & Public Health / Minimally invasive surgery / Mixed methods research / Older people / Oral hygiene / Patient Satisfaction / Prostheses / Prosthesis Design / Quality of life / Quebec / Randomized Controlled Trials as Topic / Retention / Statistics for Life Sciences / Study Protocol / Time Factors / Treatment Outcome