Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial

University of Geneva, Switzerland1 site in 1 country45 target enrollmentSeptember 2007

ConditionsEdentulous Complete Denture Wearers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Edentulous Complete Denture Wearers
Sponsor: University of Geneva, Switzerland
Enrollment: 45
Locations: 1
Primary Endpoint: Change from Baseline in Denture satisfaction
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

April 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Geneva, Switzerland

Responsible Party

Principal Investigator

Frauke Müller

Professor and Chair

University of Geneva, Switzerland

Eligibility Criteria

Inclusion Criteria

•75 years or older
•living institutionalized or receiving help for the ADL
•edentulous
•wearing complete dentures
•the lower denture had to cause discomfort to the degree that the patients were seeking treatment

Exclusion Criteria

•severe clinical depression
•poorly controlled diabetes
•immunosuppression
•treatment with bisphosphonates
•condition precluding the surgical intervention for implant placement

Outcomes

Primary Outcomes

Change from Baseline in Denture satisfaction

Time Frame: at 3, 12, 24 and 36 months

VAS-scale score to evaluate the subjective satisfaction with the denture

Secondary Outcomes

Change from Insertion in implant survival(at 3, 12, 24 and 36 months)
Change from Baseline in OHRQoL(at 3, 12, 24 adn 36 months)
Change from Baseline in MNA(at 3, 12, 24 and 36 months)
Change from Baseline in Blood markers(at 3, 12, 24 and 36 months)
Change from Baseline in Maximum bite force(at Intervention, 3, 12, 24 and 36 months)
Change from Baseline in Stimulated Saliva Flow Rate(at Intervention, 3, 12, 24 and 36 months)
Change from Insertion in peri-implant bone loss(at 3, 12, 24 and 36 months)
Changes from Baseline in Masseter Muscle Thickness(at 3, 12, 24 and 36 months)
Change from Baseline in Independence(at 12, 24 and 36 months)
Change from Insertion in Pocket depth(at 3, 12, 24 and 36 months)
Change from Baseline in cognitive function(at 12, 24 and 36 months)
Change from Baseline in BMI(at 12, 24 and 36 months)
Change from Insertion in Plaque index(at 3, 12, 24 and 36 months)
Change from Baseline in Chewing efficiency(at Intervention, 3, 12, 24 and 36 months)