Overview

This trial is active, not recruiting.

Condition edentulous complete denture wearers
Treatments implant placement, conventional reline
Sponsor University Hospital, Geneva
Collaborator University of Geneva, Switzerland
Start date September 2007
End date April 2012
Trial size 45 participants
Trial identifier NCT01928004, ITI_458_2006, MDGPA_02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
implant placement Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter)
Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
(Active Comparator)
conventional reline of mandibular complete denture
conventional reline
conventional reline of the existing mandibular complete denture

Primary Outcomes

Measure
Change from Baseline in Denture satisfaction
time frame: at 3, 12, 24 and 36 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 75 years old.

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 - dementia - poorly controlled diabetes - immunosuppression - treatment with bisphosphonates - condition precluding the surgical intervention for implant placement

Additional Information

Official title Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
Principal investigator Frauke Müller, Prof. Dr. med. dent.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.