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

Abstract

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.

3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT

“…A minimal important difference of 10 mm (10% of the VAS) was used for the estimation, as done in previous RCTs [ 41 , 54 ]. A standard deviation of 7.5 mm was chosen for the difference in satisfaction [ 55 ]. Considering a 2-sided alpha of 0.01 to compensate for the number of secondary outcomes and a power of 90%, the RCT requires n = 21 for superiority hypothesis testing (i.e., the confidence interval for between-treatment differences would exclude zero) [ 56 ].…”

“…Considering a 2-sided alpha of 0.01 to compensate for the number of secondary outcomes and a power of 90%, the RCT requires n = 21 for superiority hypothesis testing (i.e., the confidence interval for between-treatment differences would exclude zero) [ 56 ]. The final sample size is drawn from including further 20% to the planned n to compensate for possible dropouts; although withdrawals will unlikely pass 10% [ 41 , 55 , 57 ], additional participants may be lost due to aging-related issues (e.g., worsening of systemic diseases, and death).…”

Extensive Rehabilitation of a Medically Compromised Patient with Vitamin-D Deficiency Using Dental Implants: A Case Report

“…The mandibular implants enhance both retention and support as the NoVo lock attachment system was used. 8 Following this, jaw relation was recorded and a trial of waxed-up dentures was done. This enabled the exact buccolingual positioning of the metal framework.…”

İmplant Destekli̇ Overdenture Protezlerde Kullanilan Hassas Tutucular

“…Patriks ile matriks arasında bulunan küçük vida yuvası retansiyon parçasının herhangi bir gerilim olmadan geniĢlemesine izin vermektedir. 41,42 Kliniğimizde uygulanan Novaloc tutucu örneği ġekil 8"de gösterilmiĢtir. ġekil 8.…”