Dental Implant Failed Clinical Trial
Official title:
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
| NCT number | NCT04017026 |
| Other study ID # | 2019_6mm_implants |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 9, 2018 |
| Est. completion date | June 30, 2020 |
| Verified date | September 2020 |
| Source | University of Bern |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | April 8, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Partially or fully edentulous jaw - Written informed consent Exclusion Criteria: - Pregnant women/lactating women |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department for oral surgery of the zmk Bern, University of Bern | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bern |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Implant survival rates | Survival rates of short dental implants | 5-18 years | |
| Secondary | Radiographic: Annual bone loss | Distance from the implant shoulder to the marginal bone. | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Plaque-index | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Sulcus bleeding index | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Probing depth | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Prosthetic reconstruction | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Implant position | 5-18 years | |
| Secondary | Clinically: modifying risk factors on implant survival and success | Crown-to-implant ratio | 5-18 years | |
| Secondary | Patient reported outcome measures | Visual analog scale (satisfaction between 0 - 100%) | 5-18 years | |
| Secondary | Patient reported outcome measures | Oral health impact profile | 5-18 years | |
| Secondary | Implant success rates | Success rates of dental implants. Success rates according to Buser et al. 1990. | 5-18 years |
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