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

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01566227
• Other study ID #: B2012:012
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2012
• Last updated: March 26, 2012
• Start date: February 2012
• Est. completion date: April 2016

Study information

• Verified date: March 2012
• Source: University of Manitoba
• Contact: Reynaldo Todescan, Dr
• Phone: 204-7893782
• Email: Reynaldo_Todescan[@]umanitoba.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

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

Locations

Country	Name	City	State
Canada	University of Manitoba, Faculty of Dentistry	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction survey (questionnaires)	Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.	every 6 months up to three years	No
Secondary	Radiographs	Assess crestal bone level around the implants.	every 6 months up to three years	No
Secondary	Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.	The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.	baseline and 6 months	No