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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
conventional reline of the existing mandibular complete denture
University of Geneva
Geneva, Switzerland
Change from Baseline in Denture satisfaction
VAS-scale score to evaluate the subjective satisfaction with the denture
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in OHRQoL
OHIP-Edent questionnaire, 20 questions
Time frame: at 3, 12, 24 adn 36 months
Change from Baseline in cognitive function
Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
Time frame: at 12, 24 and 36 months
Change from Baseline in Independence
IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
Time frame: at 12, 24 and 36 months
Change from Baseline in MNA
Mini-nutritional Assessement questionnaire (Guigoz 1994)
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in Blood markers
Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in BMI
Body Mass Index kg/m2
Time frame: at 12, 24 and 36 months
Change from Insertion in implant survival
inserted implants in vivo
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Time frame: at 3, 12, 24 and 36 months
Change from Insertion in Pocket depth
mesial and distal peri-implant probing depth
Time frame: at 3, 12, 24 and 36 months
Change from Insertion in Plaque index
Plaque index on implants (Silness \& Loe 1963) Denture plaque index
Time frame: at 3, 12, 24 and 36 months
Change from Insertion in peri-implant bone loss
mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in Chewing efficiency
two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
Time frame: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Maximum bite force
unilateral maximal bite force measured with force gauge
Time frame: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Stimulated Saliva Flow Rate
whole saliva collected after chewing wax for 2 minutes on one side
Time frame: at Intervention, 3, 12, 24 and 36 months
Changes from Baseline in Masseter Muscle Thickness
ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
Time frame: at 3, 12, 24 and 36 months