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

This study is currently recruiting participants.

Verified March 2012 by University of Manitoba

Sponsor:

Information provided by (Responsible Party):

IPesun (1), University of Manitoba

ClinicalTrials.gov Identifier:

NCT01566227

First received: February 20, 2012

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 20, 2012

Last Updated Date

March 26, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patient Satisfaction survey (questionnaires) [ Time Frame: every 6 months up to three years ] [ Designated as safety issue: No ]

Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01566227 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Radiographs [ Time Frame: every 6 months up to three years ] [ Designated as safety issue: No ]
Assess crestal bone level around the implants.
Wear of 1 vs 2 vs 3 GPS retention components on complete dentures. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Complete Edentulism

Intervention ^ICMJE

Other: Questionnaire

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

Other Names:

Satisfaction survey
questionnaire for patient satisfaction

Study Arm (s)

Experimental: number of implants

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

Intervention: Other: Questionnaire

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Reynaldo Todescan, Dr	204-7893782	Reynaldo_Todescan@umanitoba.ca
Contact: Igor Pesun, Dr.	204-7893516	pesun@cc.umanitoba.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01566227

Other Study ID Numbers ^ICMJE

B2012:012

Has Data Monitoring Committee

Responsible Party

IPesun (1), University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Igor Pesun, DDS	Univ. of Manitoba, Faculty of Dentistry
Study Director:	Reynaldo Todescan, DDS.	Univ of Manitoba, Faculty of Dentistry
Study Chair:	Mike Barczac, DDS	Univ of Manitoba, Faculty of Dentistry

Information Provided By

University of Manitoba

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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