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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01566227
Enrollment
30
Registered
2012-03-29
Start date
2012-02-29
Completion date
2016-04-30
Last updated
2012-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Edentulism

Keywords

overdenture, implant, edentulism

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.

Interventions

OTHERQuestionnaire

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

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction survey (questionnaires)every 6 months up to three yearsAssess efficacy of treatment by analysis of patient's answer to a satisfaction survey.

Secondary

MeasureTime frameDescription
Radiographsevery 6 months up to three yearsAssess crestal bone level around the implants.
Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.baseline and 6 monthsThe force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.

Countries

Canada

Contacts

Primary ContactReynaldo Todescan, Dr
Reynaldo_Todescan@umanitoba.ca204-7893782
Backup ContactIgor Pesun, Dr.
pesun@cc.umanitoba.ca204-7893516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026