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
Verified date | June 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 86 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Department of Oral Health Sciences, University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR), ITI International Team for Implantology, Switzerland, Straumann Canada Ltd. |
Canada,
Bryant SR, Walton JN, MacEntee MI. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures. J Dent Res. 2015 Jan;94(1):36-43. doi: 10.1177/0022034514554224. Epub 2014 Oct 27. — View Citation
Gonda T, Maeda Y, Walton JN, MacEntee MI. Fracture incidence in mandibular overdentures retained by one or two implants. J Prosthet Dent. 2010 Mar;103(3):178-81. doi: 10.1016/S0022-3913(10)60026-1. — View Citation
Walton JN, Glick N, Macentee MI. A randomized clinical trial comparing patient satisfaction and prosthetic outcomes with mandibular overdentures retained by one or two implants. Int J Prosthodont. 2009 Jul-Aug;22(4):331-9. — View Citation
Walton JN, MacEntee MI. Choosing or refusing oral implants: a prospective study of edentulous volunteers for a clinical trial. Int J Prosthodont. 2005 Nov-Dec;18(6):483-8. — View Citation
Walton JN, MacEntee MI. Screening and enrolling subjects in a randomized clinical trial involving implant dentures. Int J Prosthodont. 2008 May-Jun;21(3):210-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-assessed VAS satisfaction with the mandibular 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. | Annually during 10 years after attaching the mandibular implant denture | |
Secondary | Change in self-assessed VAS satisfaction with the mandibular 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. | From baseline (before implants) to each annual followup for 10 years after attaching the mandibular implant denture | |
Secondary | Cumulative Implant Survival | Cumulative implant survival was judged by the time to the presence of clinical mobility, pain or suppuration associated with the original mandibular implants. | During the 10 years after attaching the mandibular implant denture | |
Secondary | The frequency of prosthetic maintenance events for the mandibular implant overdenture | 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. | During 10 years after attaching the mandibular implant denture | |
Secondary | Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention | This is the total professional chair-time recorded 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 | |
Secondary | Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention | 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. | From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement | |
Secondary | Time to provide prosthetic maintenance treatment for the mandibular implant overdenture | 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. | During 1 year after attachment of the mandibular implant denture | |
Secondary | Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture | 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. | During 1 year after attachment of the mandibular implant denture |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04984499 -
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1
|
||
Completed |
NCT01411683 -
Mandibular Overdentures Retained by Conventional or Mini Implants
|
N/A | |
Completed |
NCT04853459 -
A Technique for Border Molding in Complete Dentures Using Light-Cured
|
N/A | |
Not yet recruiting |
NCT06458738 -
Clinical Evaluation of a New Printable Denture Base Material
|
N/A | |
Completed |
NCT01230320 -
Simplified vs. Conventional Methods for Complete Denture Fabrication
|
N/A | |
Completed |
NCT05614635 -
Safety and Technical Performance of Plastalgin and Plastalgin Fast in Patients Requiring a Dental Impression
|
||
Active, not recruiting |
NCT05599269 -
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
|
N/A | |
Not yet recruiting |
NCT03674554 -
Prosthetic Complications of Screw Retained Restoration
|
N/A | |
Not yet recruiting |
NCT06155630 -
3D Printing for the Fabrication of Mandibular Implant Overdentures
|
N/A | |
Not yet recruiting |
NCT06393582 -
Accuracy Evaluation of Implant Impressions: A Prospective Study
|
N/A | |
Recruiting |
NCT05375045 -
Real-life Evaluation of the Safety and Performance of EUROTEKNIKA Dental Implants
|
||
Recruiting |
NCT06255522 -
Clinical and Anatomical Factors Influencing Accuracy in Fully Guided Implant Placement.
|
N/A | |
Completed |
NCT04760457 -
Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols
|
N/A | |
Completed |
NCT03126942 -
Single-implant Overdentures Retained by the Novaloc Attachment System
|
N/A | |
Enrolling by invitation |
NCT05441527 -
Use of Two Dissolvable Therapeutics Under Removable Partial Dentures
|
N/A | |
Completed |
NCT03056976 -
Cost-effectiveness of Implant Treatment for the Edentulous Mandible
|
N/A | |
Completed |
NCT04475913 -
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
|
N/A | |
Recruiting |
NCT03536468 -
Psychological Impact of Tooth Loss
|
||
Completed |
NCT03048812 -
Attachment Types for Single-implant Mandibular Overdentures: a Crossover Clinical Trial
|
N/A | |
Recruiting |
NCT02339194 -
Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
|
Phase 3 |