Edentulous Mouth Clinical Trial
Official title:
A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants
This study is a randomized clinical trial to compare patient satisfaction and prosthetic
outcomes with lower dentures retained by one or two implants. The investigators long-term
objective is to establish evidence of the cost-effectiveness of a single implant intervention
for improving tolerance to complete dentures. The investigators MAIN AIM will be to
investigate patient satisfaction between and within groups with mandibular dentures retained
by one or two implants over five years, and SECONDARILY to investigate the survival of
implants, and the frequency of events to maintain the dentures and prosthetic attachments as
clinically serviceable. Furthermore, multivariate analysis can assess the prediction of
patient satisfaction with implant dentures based on various possible factors including age,
health, demography and socioeconomic status, number of implants, and maintenance needs.
Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a
measure of overall satisfaction and various specific aspects of satisfaction such as
appearance, stability and comfort of the dentures.
The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are
at least as satisfying to patients over a five years period as those retained by two implants
for the same period.
The SECONDARY HYPOTHESES are that:
i) there is no difference over five years between groups in the survival of original
implants, or in the number of events for maintenance of the dentures or implant attachments;
and ii) using each treatment group as it's own control, there is no change in patient
satisfaction with lower dentures retained by either one or two implants during the five year
loading period.
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