Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

NCT ID: NCT01566227

Last Updated: 2012-03-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-04-30

Brief Summary

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This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

Detailed Description

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The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

Conditions

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Complete Edentulism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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number of implants

number of implants (1,2 or 3) used to retained an overdenture

Group Type EXPERIMENTAL

Questionnaire

Intervention Type OTHER

3 surveys with 10 questions each: one before, during and after treatment

Interventions

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Questionnaire

3 surveys with 10 questions each: one before, during and after treatment

Intervention Type OTHER

Other Intervention Names

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Satisfaction survey questionnaire for patient satisfaction

Eligibility Criteria

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Inclusion Criteria

* subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
* Adult age (25 plus) male or female
* Stable medical health
* Ability to participate in the study for at least 3-4 years
* Able to understand and respond to surveys used in the study
* Adequate amount of bone in the mandible to receive 3 implants.

Exclusion Criteria

history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)

* surgical limitations:
* uncontrolled systemic disease: diabetes, etc.. that may compromised healing
* irradiated surgical site
* inadequate bone height and width (re: implant size)
* inability to undergo minor oral surgery because of health or personal reasons
* psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
* Severe TMDs related to joint pathology
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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IPesun (1)

Department Head, Restorative Dentistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Igor Pesun, DDS

Role: PRINCIPAL_INVESTIGATOR

Univ. of Manitoba, Faculty of Dentistry

Reynaldo Todescan, DDS.

Role: STUDY_DIRECTOR

Univ of Manitoba, Faculty of Dentistry

Mike Barczac, DDS

Role: STUDY_CHAIR

Univ of Manitoba, Faculty of Dentistry

Locations

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University of Manitoba, Faculty of Dentistry

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Reynaldo Todescan, Dr

Role: CONTACT

204-7893782

Igor Pesun, Dr.

Role: CONTACT

204-7893516

Facility Contacts

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Reynaldo Todescan, DDS

Role: primary

204-7893782

Igor Pesun, DDS

Role: backup

204-7893516

Other Identifiers

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B2012:012

Identifier Type: -

Identifier Source: org_study_id

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