A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tooth-loss
- Sponsor
- University of British Columbia
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Self-assessed VAS satisfaction with the mandibular denture
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Ross Bryant
Assistant Professor
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •functional in English or accompanied by a responsible adult who can provide translation services
- •able to consent to, and participate in, the treatment provided
- •available for the duration of the study
- •edentulous and with at least six month's experience with conventional complete dentures
- •currently wearing conventional complete dentures that are esthetically satisfactory to the patient and technically acceptable in the judgment of the study prosthodontist(s)
- •medically/psychologically suitable for implant surgery in the judgment of the study dentists
Exclusion Criteria
- •insufficient alveolar bone height for implant(s) (\< 10 mm)
- •history of head and neck radiation
- •systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin
- •previous oral implant treatment
- •need for additional pre-prosthetic surgery
- •need for new complete dentures
- •medically/psychologically unsuitable for surgery in the opinion of the study dentists
Outcomes
Primary Outcomes
Self-assessed VAS satisfaction with the mandibular denture
Time Frame: Annually during 10 years after attaching the mandibular implant denture
Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.
Secondary Outcomes
- The frequency of prosthetic maintenance events for the mandibular implant overdenture(During 10 years after attaching the mandibular implant denture)
- Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention(From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement)
- Time to provide prosthetic maintenance treatment for the mandibular implant overdenture(During 1 year after attachment of the mandibular implant denture)
- Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention(From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement)
- Change in self-assessed VAS satisfaction with the mandibular denture(From baseline (before implants) to each annual followup for 10 years after attaching the mandibular implant denture)
- Cumulative Implant Survival(During the 10 years after attaching the mandibular implant denture)
- Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture(During 1 year after attachment of the mandibular implant denture)