Mandibular Single Implant Overdenture: a Prospective Clinical Trial
NCT ID: NCT01421849
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-08-31
2015-12-31
Brief Summary
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In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
CROSSOVER
TREATMENT
NONE
Study Groups
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Elderly with an unstable mandibular denture.
Denture implantation
In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments.
The total duration of the study will be 12 to 18 months.
Interventions
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Denture implantation
In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments.
The total duration of the study will be 12 to 18 months.
Eligibility Criteria
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Inclusion Criteria
* They have to be willing to commit to 1.5 year of participation in the study.
* They have to be edentulous for at least one year before starting the implant procedure.
Exclusion Criteria
* History of radiotherapy in the head and neck region
* Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
* Previously treated with dental implants
70 Years
90 Years
ALL
Yes
Sponsors
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Southern Implants, South Africa
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Jacques Vanobbergen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ghent, Belgium
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2011/381
Identifier Type: -
Identifier Source: org_study_id