Clinical trial NCT01928004: Mandibular Implants in Elderly Patients
Official title: Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Complete Denture Wearers
Keywords: edentulous
complete denture
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 45
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Denture satisfaction
timeFrame: at 3, 12, 24 and 36 months
Secondary outcomes:
measure: Change from Baseline in OHRQoL
timeFrame: at 3, 12, 24 adn 36 months
measure: Change from Baseline in cognitive function
timeFrame: at 12, 24 and 36 months
measure: Change from Baseline in Independence
timeFrame: at 12, 24 and 36 months
measure: Change from Baseline in MNA
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Baseline in Blood markers
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Baseline in BMI
timeFrame: at 12, 24 and 36 months
measure: Change from Insertion in implant survival
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Insertion in Pocket depth
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Insertion in Plaque index
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Insertion in peri-implant bone loss
timeFrame: at 3, 12, 24 and 36 months
measure: Change from Baseline in Chewing efficiency
timeFrame: at Intervention, 3, 12, 24 and 36 months
measure: Change from Baseline in Maximum bite force
timeFrame: at Intervention, 3, 12, 24 and 36 months
measure: Change from Baseline in Stimulated Saliva Flow Rate
timeFrame: at Intervention, 3, 12, 24 and 36 months
measure: Changes from Baseline in Masseter Muscle Thickness
timeFrame: at 3, 12, 24 and 36 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: University of Geneva
name: Frauke Müller, Prof. Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.
citation: Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.