Dental Implants
Conditions
Brief summary
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.
Interventions
PROCEDUREearly loading
two TiZr implants on SLA surface
PROCEDUREimmediate loading
four TiZr implants on SLA surface
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At patient level: * Written informed consent * Age ≥ 18 years * Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year * Patient is unsatisfied with mandibular denture to the degree that he/she seeks treatment * At site level: * Healed edentulous mandible (minimum 8 weeks since last extraction) * Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10 mm (length) implants * Opposing dentition: complete denture on a edentulous maxilla * Physical status (PS) 1 and 2 (American Society of Anesthesiologists)
Exclusion criteria
* At patient level * Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol * Any disorder that would interfere with wound healing or represent a contraindication for oral surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates * Pregnancy or lactation * Heavy smoking habit with \> 20 cig/d * Severe bruxism or clenching habits, present oro-facial pain * At site level: * Ridge defects requiring staged bone augmentation procedures (simultaneous Guided Bone Regeneration (GBR) within the ridge contour allowed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Oral Health Assessment Index (GOHAI) | One-year follow-up | Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL). Scores 0-60: higher values represent lower OHRQoL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success | at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up | Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success |
| Prosthetic Survival | Baseline, follow-up (up to 365 days) | Prosthetic Survival (yes/no): is the denture still in place? |
| Chewing Efficiency | Baseline, follow-up (up to 365 days) | Color mixing test |
| Additional Oral Health Impact Profile for edentulism (OHIP-EDENT) | Follow-up (up to 365 days) | Change from baseline questionnaires |
| Additional PROM Denture Satisfaction Index (DSI) | Baseline, follow-up (up to 365 days) | Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm) |
| Plaque Index | at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up | 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 |
| Bleeding Index | at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up | 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 |
| Pocket Probing depth | at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up | depth measured in mm |
| Time-Cost-Analysis | After surgery, after implants loading, after follow-up (up to 365 days) | 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 |
| Cost Effectiveness and Willingness to Pay | Total change and time at 1y follow-up | 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 |
| Implant Survival | at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up | Survival (yes/no) |
| In-vivo evaluated loss of retentive force | after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days) | Measurement with a hand-held digital force gauge |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORBeat Wallkamm, Dr
Private Practice
STUDY_DIRECTORMartin Schimmel, Prof
University of Bern
Outcome results
None listed