Single-Implant Overdentures Retained by a Novel Attachment: A Mixed Methods Crossover Randomized Clinical Trial.

Abstract

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.