Complete Denture, Complete Lower Denture, Edentulous Mouth, Tooth-loss
Conditions
Keywords
Implant-Supported Denture, Single-Implant Denture, Patient Satisfaction, Edentulous Mandible, Dental Implants, Standard of Care, Randomized Clinical Trial
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.
Interventions
PROCEDURE1 implant placed surgically in the mandibular midline
Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
PROCEDURE2 implants placed surgically in the mandibular canine sites
Participants receive implants bilaterally in the site of the mandibular canines using a surgical flap procedure with local anaesthesia.
PROCEDURESoft reline (Coe Comfort) of the existing complete lower denture
Participants receive a soft reline of the existing complete lower denture approximately 10 days after placement of the implant(s).
DEVICE2.25mm ball patrix placed on 1 healed implant
A 2.25mm ball patrix is screwed onto the 1 implant approximately six weeks after placement of the implant.
DEVICE2.25mm ball patrices placed on 2 healed implants
2.25mm ball patrices are screwed onto the 2 implants approximately six weeks after placement of the implants.
PROCEDUREReline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture
Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 1 retentive matrix in the denture-base to retain on the implant.
PROCEDUREReline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture
Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 2 retentive matrices in the denture-base to retain on the implants
Sponsors
ITI International Team for Implantology, Switzerland
Canadian Institutes of Health Research (CIHR)
Straumann Canada Ltd.
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-assessed VAS satisfaction with the mandibular denture | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Implant Survival | During the 10 years after attaching the mandibular implant denture | Cumulative implant survival was judged by the time to the presence of clinical mobility, pain or suppuration associated with the original mandibular implants. |
| The frequency of prosthetic maintenance events for the mandibular implant overdenture | During 10 years after attaching the mandibular implant denture | The frequency of prosthetic maintenance treatment events for the mandibular denture including adjustment, reattachment, or replacement of implant attachment components, and denture base fractures, relining or rebasing, and denture replacement with a new lower 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 | This is the total professional chair-time recorded to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention. |
| 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 | 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. |
| Time to provide prosthetic maintenance treatment for the mandibular implant overdenture | During 1 year after attachment of the mandibular implant denture | This is the total professional chair-time recorded to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing. |
| Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture | During 1 year after attachment of the mandibular implant denture | This is the total cost of components and professional and dental laboratory fees to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing. |
| 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 | This is the total cost of components and professional and dental laboratory fees to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention. |
Countries
Canada
Outcome results
None listed