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| Name | Class |
|---|---|
| Federal University of Uberlandia | OTHER |
| UNESP, Câmpus de Araraquara | OTHER |
| Faculdade ILAPEO | UNKNOWN |
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This is a post-market prospective observational study to prospectively collect clinical data to confirm the long-term safety and clinical performance of implants and abutments Helix Short in a daily dental practice setting, by means of success and survival rates of these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the IFU, identify and analyze emerging risks on the basis of factual evidence, and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients with maxillary and mandible atrophy in need of one or more dental implants and who were evaluated as suitable for the installation of Helix Short implants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant | Device | Dental Implant placement and loading. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant success rate | Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading. | From the implant loading to the 36-months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival rate | Implant survival rate | From the implant loading to the 36-months of follow-up |
| Prosthetic survival and success rates | Prosthetic results |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with atrophic maxilla and mandible, who need of one or more dental implants with opposing dentition (natural teeth or teeth/implant-supported fixed restorations) and who qualify for placement of Helix Short implants.
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| From the implant loading to 36-months of follow-up |
| Change in peri-implant bone level | Evaluating bone loss | From the implant loading to 36-months of follow-up |
| Soft tissue assessment - Visible Plaque | Visible plaque index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting visible plaque. | From the implant loading to 36-months of follow-up |
| Evaluation of the crown/implant ratio | Evaluation of the crown/implant ratio | From the implant loading to 36-months of follow-up |
| Risk factors for Implant Loss | Risk factors for implant loss will be assessed performing statistical analysis between implants losses and characteristics of these losses (implant and procedures' characteristics). | From the enrollment to 36-months of follow-up |
| Type of load and time for final prosthesis | If immediate or late loading. | From the implant placement to 36-months of follow-up |
| Patient satisfaction | Patient satisfaction assessment through (Oral Health Impact Profile-14) questionnaire. It is made of 14 questions to be answered through a set of Likert scale. The final score is calculated based on the answers for each question, and it is ranged from 0 to 56. The highest score indicates a greater negative impact of oral health on a person's well-being. The questions include seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and social disadvantage. The questionnaire will be applied in different times of follow-up during the study. | From the enrollment to 36-months of follow-up. |
| Clinician satisfaction with all devices used and procedures | Clinician satisfaction assessment through a questionnaire about implant placement and rehabilitation outcomes, and the answers through a visual analogue scale (VAS) from 1 to 10. The highest scores means better outcome. | From the implant placement to 36-months of follow-up. |
| Adverse events and residual risks related to the implant, prosthetic component, and prosthesis. | Monitoring of adverse events, including implant and prothesis loss to evaluate their association with implant's and patient's charactheristics. | From the enrollment to 36-months of follow-up. |
| Soft tissue assessment - Marginal Bleeding Indexes | Marginal bleeding index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting marginal bleeding. | From the implant loading to 36-months of follow-up |
| Soft tissue assessment - Bleeding on probing | Bleeding on probing will be assessed as present or absent, using a periodontal probe to the bottom of the clinical sulcus, in the buccal surface of each implant site. Bleeding will be considered positive if it occurs within 10 to 15 seconds after probing. | From the implant loading to 36-months of follow-up |
| Soft tissue assessment - Keratinized gingiva | Calibrated probes of 1, 2, 3, 5, 7, and 10 mm will be used to measure the range of keratinized gingiva as the distance from the gingival margin to the mucogingival junction, at the center of the buccal surface. The thickness of the keratinized tissue will be assessed and categorized as thick or thin. This assessment will be based on the transparency of the same periodontal probe through the gingival margin during the probing of the sulcus in the mid-buccal region. If the outline of the underlying periodontal probe could be seen through the gingiva, it was classified as thin (score: 0); otherwise, it was classified as thick (score: 1) | From the implant loading to 36-months of follow-up |
| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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