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| Name | Class |
|---|---|
| Klockner Implant System S.A. | UNKNOWN |
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NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.
NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Control group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test group | Procedure | 3.0mm diameter implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal bone level difference | To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS. | The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient related outcomes | - Level of discomfort - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 no discomfort and 4 very severe discomfort) | At 1, 2 and 12 weeks |
| Patient Related Outcomes |
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Inclusion Criteria:
Patients:
Site:
Implants:
Exclusion Criteria:
Patients
Site
Implant
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group |
| Procedure |
4.0 diameter implant + guided bone regeneration |
|
Willingness of undergoing same surgical procedure - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 will never undergo this surgery again and 4 no problem to repeat this surgery)
| At 1, 2 and 12 weeks |
| Patient Related Outcomes | - Level of pain perceived - during first 7 days after surgery (VAS scale): 0-100 (being 0 no pain and 100 intolerable pain) | At 7 days |
| Patient Related Outcomes | Medication required: Number of ibuprofen tablets taken between the 2nd and the 7th day. | At 7 days |
| Implant survival criteria: | Defined as the implant being still in function | 12 months |
| Implant success criteria: | Defined as absence of:
| 12 months |
| Prosthesis success criteria |
| 12 months |
| Resonance frequency analysis | Resonance frequency analysis using Penguin ® will be measured immediately after implant placement, when taking implant impressions | Implant surgery and after 12 months |
| Level of keratinized tissue surrounding the implants | Level of keratinized tissue will be measured from the gingival margin of the restored implant to the mucogingival line using a periodontal millimetre probe. | 12 months |
| Peri-implant mucosal thickness using a millimetre probe | 12 months |
| Presence of post-surgical complications | Defined as absence of:
| At 1, 2 and 12 weeks |
| Presence of peri-implant health | Defined as:
| At 12 weeks, 6 and 12 months |
| Presence of prosthetic complications | Defined as:
| At 6 and 12 months |
| D008722 | Methods |