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| Name | Class |
|---|---|
| Straumann AG | UNKNOWN |
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Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.
It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental patients | Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implants (Straumann Roxolid® / SLActive®) | Device | In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation. In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival of implants and suprastructure. Measure: survival rates | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability | Within-subject comparison of primary (at implant placement) and secondary (at implant exposure) stability of short versus regular length implants. Measure / device: Resonance Frequency Analysis (RFA) | 3 months |
| Success |
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Inclusion Criteria:
General criteria:
Specific criteria:
Exclusion Criteria:
General criteria:
Specific criteria:
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Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic)
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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|
Success of implants and suprastructure. Measure: success rates
Biological success:
No detectable clinical mobility (hand testing)
No radiolucency surrounding the total surface of the implant
No persistent pain refractory to medical therapy
No recurrent peri-implant infection
Technical success:
| 5 years |
| Oral health-related quality of life | Oral health-related quality of life (OHRQoL). Measure: questionnaire - 49-item Oral Health Impact Profile (OHIP) with a 5-point ordinal rating scale (possible range of summary scores: 0-196 with higher scores indicating more impairment) | 5 years |
| Patient satisfaction | Patient satisfaction. Measure: questionnaire - Visual analogue scales (VAS) on ease of cleaning, speech, comfort, esthetic, stability, chewing ability, masticatory function, and oral health (possible range of scores: 0-10 for each item with higher scores indicating more satisfaction) | 5 years |
| D007571 |
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009066 | Mouth, Edentulous |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |