Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
86 participants
INTERVENTIONAL
2002-11-30
2027-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 implant
Participants receive the following:
1 implant placed surgically in the mandibular midline; Soft reline of the existing complete lower denture; 2.25mm ball patrix placed on 1 healed implant; and Reline with 1 retentive matrix in the lower denture.
1 implant placed surgically in the mandibular midline
Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
Soft 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).
2.25mm 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.
Reline (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.
2 implants
Participants receive the following:
2 implants placed surgically in the mandibular canine sites; Soft reline of the existing complete lower denture; 2.25mm ball patrices placed on 2 healed implants; and Reline with 2 retentive matrices in the lower denture.
2 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.
Soft 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).
2.25mm 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.
Reline (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
Interventions
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1 implant placed surgically in the mandibular midline
Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
2 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.
Soft 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).
2.25mm 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.
2.25mm 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.
Reline (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.
Reline (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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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ITI International Team for Implantology, Switzerland
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Straumann Canada Ltd.
UNKNOWN
University of British Columbia
OTHER
Responsible Party
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Ross Bryant
Assistant Professor
Principal Investigators
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Stephen R. Bryant, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Michael I. MacEntee, LDS, PhD
Role: STUDY_DIRECTOR
University of British Columbia
Joanne N. Walton, DDS
Role: STUDY_DIRECTOR
University of British Columbia
Locations
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Department of Oral Health Sciences, University of British Columbia
Vancouver, British Columbia, Canada
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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H02-70082
Identifier Type: -
Identifier Source: org_study_id
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