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Attachment Types for Single-implant Mandibular Overdentures: a Crossover Clinical Trial

NCT03048812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-09-18

No results posted yet for this study

Summary

Dental implants are often the preferred treatment option and in some clinical scenarios they are considered the standard of care to restore missing or damaged teeth, due to the limitations of conventional treatments. For fully edentulous subjects, conventional tissue-supported dentures in some cases are associated with severe subjective complaints and difficult adaptation, mainly the mandibular denture, resulting in limited function and detrimental effects on oral health-related quality of life, especially for older patients. The use of implants to retain a mandibular denture (overdenture) has been recommended as a suitable and low-cost alternative to improve denture stability, with positive effects on oral comfort and function. The two-implant mandibular overdenture has been considered an effective design to achieve clinical benefits for patients. However, the main problem facing two-implant overdenture is the high cost of implantation and the relative complexity of the surgical intervention, so the use of a single midline implant to retain a mandibular overdenture was suggested as a more viable solution for reducing costs and complexity of treatment with similar benefits compared to solutions with higher number of implants. Nevertheless, there are few studies that compared the performance of different retention systems and their effects on patient-centered outcomes, such as satisfaction with the dentures, oral health-related quality of life, individual preferences and other subjective ratings of clinical outcomes. Thus, the aim of this randomized clinical trial with a crossover design is to investigate the changes in clinical and patient-reported outcomes following the use of different retention systems for a single implant-retained mandibular overdenture Hypothesis: it was hypothesized that clinical and patient-reported outcomes of a single-implant mandibular overdenture is dependent on the type of retention system, and patients have distinct preferences in relation to different attachments

Conditions

  • Edentulous Mouth
  • Complete Edentulism

Interventions

DEVICE

O'Ring Attachment (A)

Attachment A will be inserted in three months of follow up,followed by treatment B in a random order

DEVICE

Equator Attachment (B)

Attachment B will be inserted in three months of follow up,followed by treatment A in a random order

Sponsors & Collaborators

  • Universidade Federal de Goias

    lead OTHER

Principal Investigators

  • Claudio R Leles, Doctorate · UFG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-05-31
Completion
2018-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048812 on ClinicalTrials.gov