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Complete Lower Dentures on 1 or 2 Implants

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ClinicalTrials.gov Identifier: NCT02117856
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
ITI International Team for Implantology, Switzerland
Canadian Institutes of Health Research (CIHR)
Straumann Canada Ltd.
Information provided by (Responsible Party):
Ross Bryant, University of British Columbia

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.


Condition or disease Intervention/treatment Phase
Tooth-loss Edentulous Mouth Complete Denture Complete Lower Denture Procedure: 1 implant placed surgically in the mandibular midline Procedure: 2 implants placed surgically in the mandibular canine sites Procedure: Soft reline (Coe Comfort) of the existing complete lower denture Device: 2.25mm ball patrix placed on 1 healed implant Device: 2.25mm ball patrices placed on 2 healed implants Procedure: Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture Procedure: Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants
Study Start Date : November 2002
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Active Comparator: 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.

Procedure: 1 implant placed surgically in the mandibular midline
Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
Other Name: Implant is Solid Screw, SLA surface, Straumann Canada

Procedure: 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).
Other Name: Soft reline is Coe Comfort, GC Corporation

Device: 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.
Other Name: Patrix is Spherical Stud Retentive Anchor, Straumann Canada

Procedure: 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.
Other Names:
  • Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada
  • Matrix is Straumann Gold Matrix, Straumann Canada

Active Comparator: 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.

Procedure: 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.
Other Name: Implants are Solid Screw, SLA surface, Straumann Canada

Procedure: 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).
Other Name: Soft reline is Coe Comfort, GC Corporation

Device: 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.
Other Name: Patrix is Spherical Stud Retentive Anchor, Straumann Canada

Procedure: 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 Names:
  • Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada
  • Matrix is Straumann Gold Matrix, Straumann Canada




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in self-assessed VAS satisfaction with the mandibular denture [ Time Frame: 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.

  2. Cumulative Implant Survival [ Time Frame: 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.

  3. The frequency of prosthetic maintenance events for the mandibular implant overdenture [ Time Frame: 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.

  4. Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention [ Time Frame: 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.

  5. Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention [ Time Frame: 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.

  6. Time to provide prosthetic maintenance treatment for the mandibular implant overdenture [ Time Frame: 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.

  7. Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117856


Locations
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Canada, British Columbia
Department of Oral Health Sciences, University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Sponsors and Collaborators
University of British Columbia
ITI International Team for Implantology, Switzerland
Canadian Institutes of Health Research (CIHR)
Straumann Canada Ltd.
Investigators
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Principal Investigator: Stephen R. Bryant, DDS, PhD University of British Columbia
Study Director: Michael I. MacEntee, LDS, PhD University of British Columbia
Study Director: Joanne N. Walton, DDS University of British Columbia

Publications of Results:
Other Publications:
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Responsible Party: Ross Bryant, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02117856     History of Changes
Other Study ID Numbers: H02-70082
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Keywords provided by Ross Bryant, University of British Columbia:
Implant-Supported Denture
Single-Implant Denture
Patient Satisfaction
Edentulous Mandible
Dental Implants
Standard of Care
Randomized Clinical Trial

Additional relevant MeSH terms:
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Mouth, Edentulous
Tooth Loss
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Periodontal Diseases