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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-group | Experimental | Two Tissue Level TiZr Sand blasted long grit acid-etched (SLA) implants placed in positions 33 and 43 (diameter 3.3mm, length ≥10mm), early loading |
|
| Experimental-group | Experimental | Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early loading | Procedure | two TiZr implants on SLA surface |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Oral Health Impact Profile for edentulism (OHIP-EDENT) | Change from baseline questionnaires | Follow-up (up to 365 days) |
| Additional PROM Denture Satisfaction Index (DSI) | Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm) |
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Inclusion Criteria:
At patient level:
At site level:
Exclusion Criteria:
At patient level
At site level:
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| Name | Affiliation | Role |
|---|---|---|
| Beat Wallkamm, Dr | Private Practice | Principal Investigator |
| Martin Schimmel, Prof | University of Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice Dr. B. Wallkamm | Langenthal | Canton of Bern | 4900 | Switzerland | ||
| University of Bern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42226346 | Derived | Schimmel M, Leles CR, Schenk N, Janner SFM, Wallkamm B, Suter VGA, Abou-Ayash S, Raabe C. Mandibular Overdentures on Four Immediately Loaded Mini-Implants Versus Two-Delayed Loaded Regular Implants: 1-Year, Two-Center RCT on Patient-Reported Outcomes. Clin Oral Implants Res. 2026 Jun 1. doi: 10.1111/clr.70143. Online ahead of print. |
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It is not planned to use the data of this study for future research.
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| immediate loading |
| Procedure |
four TiZr implants on SLA surface |
|
| Baseline, follow-up (up to 365 days) |
| Implant Survival | Survival (yes/no) | 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 | 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? | Baseline, follow-up (up to 365 days) |
| Chewing Efficiency | Color mixing test | 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 | 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
| 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 | 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 | 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 | Total change and time at 1y follow-up |
| In-vivo evaluated loss of retentive force | Measurement with a hand-held digital force gauge | after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days) |
| Bern |
| 3010 |
| Switzerland |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |