BackgroundOverdentures 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/designWe 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.DiscussionOur 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 registrationClinicalTrials.gov, NCT03126942. Registered on 13 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2606-7) contains supplementary material, which is available to authorized users.
Introduction: Single-implant mandibular overdentures (SIMOs) are one of the least invasive implant treatments for edentulism. The new Novaloc attachment system can improve the clinical performance of implant-retained overdentures but has not been tested for SIMOs. Objectives: To compare Novaloc and a gold standard system (Locator) for SIMOs in an edentate elderly population in terms of patient-reported outcomes and device- and treatment-related complications. Methods: In this single-center crossover randomized clinical trial (RCT), 10 edentulous participants received an implant in the lower midline and had their lower complete dentures converted to SIMOs. The participants received each attachment system for 3 mo in a randomized order, followed by measurement of patient satisfaction and oral health–related quality of life via the McGill Denture Satisfaction Questionnaire and the Oral Health Impact Profile for Edentulous People questionnaire, respectively. Complications were registered throughout the RCT. Patients were interviewed for their experiences with SIMOs and preference for one of the attachment systems. Quantitative analysis employed mixed linear models and chi-square tests (α = 0.05), whereas interview data underwent thematic analysis and, in turn, integration into quantitative data (mixed methods explanatory design). Results: All 10 randomized participants completed the trial. Mean ± SD general satisfaction was 92% ± 8% with Novaloc versus 85% ± 13% with Locator (mean difference, 9%; 95% CI, 1% to 17%). For specific McGill Denture Satisfaction Questionnaire items, only denture stability was significantly increased for Novaloc. Seven participants preferred Novaloc over Locator at the end of the RCT (chi-square, P = 0.045). No difference was found between the attachments in terms of oral health–related quality of life based on the Oral Health Impact Profile for Edentulous People and complications. Thematic analysis revealed high patient satisfaction with SIMOs, with denture stability the main criterion for their satisfaction and attachment preference. Conclusion: Among elderly edentulous patients wearing SIMOs, Novaloc led to increased patient satisfaction and preference. Better patient-perceived denture stability may explain this result. The attachment systems exhibited similar short-term maintenance needs. Trial Registration: ClinicalTrials.gov: NCT03126942 (first registered on April 13, 2017). Secondary identifiers: A03-M07-17A (McGill University, Institutional Review Board) and 2018-3873 (McGill University Health Centre, Research Ethics Board). Knowledge Transfer Statement: The results of this mixed methods study can be used by clinicians when choosing which attachment system to use for SIMOs. Results suggest that edentulous patients prefer attachments with a better-defined seating position, such as that of the Novaloc system, as opposed to the nylon matrix on metallic abutment of the Locator system.
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