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NCT04017026 Clinical Trial

Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date September 2020
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Implantation
Implantation of 6 mm short implants

Locations
Country Name City State
Switzerland Department for oral surgery of the zmk Bern, University of Bern Bern

Sponsors (1)
Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome
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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