H0: "Within the first year post-placement, four interforaminally placed, immediately loaded 2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show improved patient-reported outcome measures (PROMS) compared to two interforaminally placed, early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular overdenture."The specific aim is to compare both treatment alternatives to evaluate which one may be recommended for elderly edentulous patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
two TiZr implants on SLA surface
four TiZr implants on SLA surface
Private Practice Dr. B. Wallkamm
Langenthal, Canton of Bern, Switzerland
University of Bern
Bern, Switzerland
Geriatric Oral Health Assessment Index (GOHAI)
Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL). Scores 0-60: higher values represent lower OHRQoL
Time frame: One-year follow-up
Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)
Change from baseline questionnaires
Time frame: Follow-up (up to 365 days)
Additional PROM Denture Satisfaction Index (DSI)
Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)
Time frame: Baseline, follow-up (up to 365 days)
Implant Survival
Survival (yes/no)
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Implant Success
Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Prosthetic Survival
Prosthetic Survival (yes/no): is the denture still in place?
Time frame: Baseline, follow-up (up to 365 days)
Chewing Efficiency
Color mixing test
Time frame: Baseline, follow-up (up to 365 days)
Plaque Index
Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying 1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer
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Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Bleeding Index
Bleeding Index Scores 0-3 0= Healthy gingival 1. Gingival look inflamed, but don't bleed when probed 2. Gingival look inflamed and bleed when probed 3. Ulceration and spontaneous bleeding
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Pocket Probing depth
depth measured in mm
Time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
Time-Cost-Analysis
Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration
Time frame: After surgery, after implants loading, after follow-up (up to 365 days)
Cost Effectiveness and Willingness to Pay
Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI
Time frame: Total change and time at 1y follow-up
In-vivo evaluated loss of retentive force
Measurement with a hand-held digital force gauge
Time frame: after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)