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

ABSTRACT: 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.

SUBMITTER: de Souza RF

PROVIDER: S-EPMC5913792 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

de Souza Raphael F RF Bedos Christophe C Esfandiari Shahrokh S Makhoul Nicholas M NM Dagdeviren Didem D Abi Nader Samer S Jabbar Areej A AA Feine Jocelyne S JS

Trials 20180423 1

<h4>Background</h4>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 ...[more]

PMID: 29685161

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Project description:IntroductionSingle-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.ObjectivesTo 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.MethodsIn 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).ResultsAll 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.ConclusionAmong 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 registrationClinicalTrials.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 statementThe 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.

Project description:BackgroundComplete tooth loss is a significant global oral health issue, particularly impacting older individuals with lower socioeconomic status. Computer-assisted technologies enhance oral healthcare access by the elderly. Despite promising in vitro reports on digital denture materials, evidence from randomized clinical trials (RCTs) is lacking to verify their performance. This cross-over RCT will investigate whether 3D-printed implant-retained mandibular overdentures (IMO) are more satisfactory for edentulous seniors than those made through traditional methods.Methods/designWe will recruit 26 completely edentulous participants (any sex/gender) based on the following eligibility criteria: age ≥ 60 years, no tooth extraction in the past 12 months, two implants in the lower jaw, and need for new dentures in both jaws. Each participant will receive two denture pairs, either manufactured by 3D printing or traditionally, to be worn in a random order. A timeline of 3 months with each denture pair will be considered for outcome assessment (total: 6 months). Patient satisfaction with dentures will be measured by the McGill Denture Satisfaction Questionnaire. We will evaluate other patient-reported outcomes (including oral health-related quality of life) as well as clinician-assessed quality and cost. At the end of the trial, participants will choose which denture pair they wish to keep and interviewed about their experiences with the 3D-printed IMO. The quantitative and qualitative data will be incorporated through an explanatory mixed-methods strategy. A final quantitative assessment will happen after 12 months with the preferred IMO to assess the long-term performance and maintenance needs.DiscussionThis mixed-methods RCT will explore patient experiences with 3D-printed IMOs, aiming to assess the potential for altering clinical practice and dental public health policies. Our results will inform policies by showing whether 3D printing offers comparable outcomes at lower costs, facilitating greater access to oral care for the elderly.Trial registrationClinicalTrials.gov, NCT06155630, Registered on 04 December 2023. https://classic.Clinicaltrialsgov/ct2/show/NCT06155630.

Project description:AimTo evaluate the influence of primary insertion torque (IT) values of narrow dental implants on the peri-implant health, implant stability, immunoinflammatory responses, bone loss, and success and survival rates.MethodsThirty-one edentulous patients received two narrow implants (2.9x10mm, Facility NeoPoros) to retain mandibular overdentures. The implants were categorized in four groups according to their IT: (G1) IT > 10 Ncm; (G2) IT ≥ 10Ncm and ≤ 30 Ncm; (G3) IT >30Ncm and < 45Ncm; (G4) IT ≥ 45Ncm, and all implants were loaded after 3 months of healing. The following clinical outcomes were evaluated 1, 3, 6, and 12 months after implant insertion: (i) peri-implant tissue health (PH), gingival index (GI), plaque index (PI), calculus presence (CP), probing depth (PD), and bleeding on probing (BOP); (ii) implant stability quotient (ISQ) by resonance frequency analysis; and (iii) IL-1β and TNF-α concentration in the peri-implant crevicular fluid. The marginal bone level (MBL) and changes (MBC) were evaluated. The Chi2 test, Kruskal-Wallis test, mixed-effects regression analysis, and the Kendall rank correlation coefficient were used for statistical analysis (α = 5%).ResultsG1 presented the highest PD at all evaluated periods. G2 presented higher PI at month 6 and 12. G4 showed increased GI at month 3 and 12 and more CP at month 1 (p=.003). G2 and G4 had higher ISQ values over the study period, while those from G1 and G3 presented lower ISQ values. The IL-1β concentration increased until month 12 and was independent of IT and bone type; G4 had a higher IL-1β concentration in month 3 than the other groups (p=.015). The TNF-α release was negatively correlated with IT, and TNF-α release was highest in G1 at month 12. The MBL immediately after surgery and the MBC at month 12 were similar between the groups, and G4 presented a positive MBC at month 12. The survival and success rates were 75% for G1, 81.3% for G2, 64.3% for G3, and 95% for G4.ConclusionThe IT did not influence the clinical outcomes and the peri-implant immunoinflammatory responses and was weakly correlated with the narrow dental implants primary stability. The observed success rates suggest that the ideal IT for atrophic fully edentulous patients may deviate from the standardized IT of 32 Ncm.

Project description:AimThe aim of this study was to examine systematically the data published on the cost and cost-effectiveness of mandibular two-implant-retained overdentures compared to other removable prosthodontic treatment options for edentulous mandible.Settings and designIt is a systematic review which analyses the available data from the prospective and retrospective studies and randomized clinical trials to find out costs and cost effectiveness of different removable treatment modalities for completely edentulous mandible. The study protocol was decided according to PRISMA guidelines.Materials and methodsThe search was limited to English literature only and included an electronic search through PubMed Central, Cochrane Central Register of Controlled Trials, and complemented by hand-searching. All clinical trials published up to August 2019 were included (without any starting limit). Two independent investigators extracted the data and assessed the studies.Statistical analysis usedNo meta-analysis was conducted because of the high heterogeneity of data.ResultsOut of the initial 509 records, only nine studies were included. The risks of bias of individual studies were assessed. Six studies presented data on cost and cost analysis only. The rest three articles provided data on cost-effectiveness. The overall costs of implant overdentures were higher than the conventional complete dentures. However, implant overdentures were more cost-effective when compared to conventional complete dentures. Single-implant overdentures are also less expensive than two-implant overdentures. Overdentures supported by two or four mini-implants were also reported as more cost-effective than conventional two-implant-supported overdentures.ConclusionsTwo-implant-retained overdentures are more expensive but cost-effective than the conventional complete dentures. Two- or four-mini-implant-retained overdentures are less expensive than two-implant-retained overdentures, but there is a lack of long-term data on aftercare cost and survival rate of mini-implants. Single-implant overdentures are also less expensive than the two-implant-retained overdentures. The differences of the aftercare costs of different attachment systems for implant overdentures were not significant. There is a need of further studies on comparative cost-effectiveness of different types of implant overdentures.

Project description:BackgroundCross-system interventions can help integrate services across different service delivery systems but require organizations to establish strong collaborative relationships for implementation. Contingency theory suggests that the effectiveness of different collaborative strategies (i.e. specific ways organizations align operations and services) varies by context. This paper describes a study of different strategies for fostering collaboration between child welfare and substance abuse treatment agencies and the conditions under which they are effective for implementation. We also describe the development and piloting of the Collaborating Across Systems for Program Implementation (CASPI) tool-a decision-making guide intended to help researchers and organizational leaders identify and use appropriate collaborative strategies for their context.Methods/designThis multisite longitudinal, mixed methods study, leverages a naturally occurring implementation initiative -- in up to 17 Ohio counties -- to implement Ohio START (Sobriety Treatment and Reducing Trauma). START is a child welfare model that requires strong collaboration with local substance use treatment organizations to promote integrated services. During the first two years, we will identify collaborative strategies associated with improved START implementation (penetration and fidelity) and service delivery outcomes (timeliness), given system, and organizational features. We will conduct a convergent mixed methods study drawing on worker surveys, agency documents, administrative data, formal partner agreements, and group interviews. Data will be integrated and analyzed using Qualitative Comparative Analysis (QCA). To develop the CASPI, an expert panel comprised of implementation experts, and community stakeholders will convene to synthesize our findings and develop contents (including a decision tree). During the final year of the study, we will assess the acceptability, appropriateness, and feasibility of the CASPI in a randomized vignette experiment, and a pilot-test with 3 child welfare agencies that have not yet implemented START.DiscussionOur results will lay the groundwork for a larger controlled trial that will test the CASPI's effectiveness for supporting effective and efficient implementation of cross-system interventions like START. The CASPI is expected to help leaders and researchers select and use collaboration strategies tailored to their context and be applicable in a wide range of settings including rural communities. Our work also advances system-level implementation strategies.Trial registrationNCT03931005 , Registered April 29, 2019.

Project description:IntroductionAwareness of the benefits of cochlear implants is low, and barriers such as fear of surgery and ongoing rehabilitation have been noted. Perceived stigma associated with hearing loss also plays a key role, with many adults not wanting to appear old or be identified as a person with a disability. In effect, a cochlear implant makes deafness visible. New technologies have led to a smaller external profile for some types of cochlear implants, but qualitative assessments of benefit have not been explored. This study will examine cochlear implant aesthetics and cosmetics, and its impact on perceived stigma, social interactions, communication and quality of life. A particular focus will be the examination of totally implantable device concepts. A secondary aim is to understand what research techniques are best suited and most appealing for cochlear implant recipients, to assist in future study design and data collection methods.Methods and analysisThis study utilises a mixed-methods design. Three datasets will be collected from each participant with an expected sample size of 10-15 participants to allow for data saturation of themes elicited. Each participant will complete a demographic questionnaire, a quickfire survey (a short concise questionnaire on a topic of research familiarity and preference) and a semi-structured interview. Questionnaire and quickfire survey data will be analysed using descriptive statistics. Interviews will be transcribed and analysed thematically. All participants will be adults with more than 1 year of experience using cochlear implants.Ethics and disseminationThis study has been granted ethical approval from Macquarie University (HREC: 520211056232432) and meets the requirements set out in the National Statement on Ethical Conduct in Human Research. Study findings will be disseminated widely through international peer-reviewed journal articles, public and academic presentations, plain language summaries for participants and an executive summary for the project funder. This work was supported by Cochlear Limited (Cochlear Ltd). The funder will have no role in conducting or reporting on the study.

Project description:IntroductionRehabilitation is a key element in most cancer care policies in recognition of the often unmet physical, psychological and social needs among the rising numbers of patients with cancer. A systematic assessment of patients' needs and available rehabilitation services constitute the foundation for timely, comprehensive and coordinated cancer rehabilitation. This study aims to provide insight into the current organisation and practice of cancer rehabilitation in Denmark with special emphasis placed on the assessment of patients' needs and availability of services across the cancer treatment trajectory.Methods and analysisA cross-sectional design using a mixed methods approach will be used in order to analyse the readiness for cancer rehabilitation in different sectors and from differing perspectives. Substudy 1 consists of an electronic survey among the 98 Danish municipalities and focuses on the availability and use of cancer rehabilitation services for patients with all types of cancers. In substudy 2, a survey among the 19 surgical and 12 oncological departments involved in colorectal cancer treatment in Denmark is conducted in order to describe the current clinical practice regarding the assessment of rehabilitation needs and referral to services. Substudy 3 involves a retrospective clinical audit and semistructured interviews at four randomly selected surgical and oncological departments treating colorectal patients with cancer in order to elucidate current needs assessment practices.Ethics and disseminationThe study was approved by the Danish Data Protection Agency and will be conducted in accordance with the principles of the Helsinki Declaration Representatives from municipalities and clinical practice are engaged in the design and execution of the study in order to ensure the usefulness of survey instruments, reflexive interpretation of data and transfer of implications into practice.ResultsPublished in international peer-reviewed scientific journals and presented at conferences, seminars and as short reports.

Dataset Information

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

Publications

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

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