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

September 2, 2020 updated by: University of Bern
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department for oral surgery of the zmk Bern, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients treated with a 6mm short implant at the University of Bern were recalled for a clinical and radiographic follow-up examination.

Description

Inclusion Criteria:

  • Partially or fully edentulous jaw
  • Written informed consent

Exclusion Criteria:

  • Pregnant women/lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
6 mm implants
Patients were treated with 6mm short implants (Straumann, SLA, SLActive, 4.1 or 4.8 mm in diameter).
Device: Implantation
Implantation of 6 mm short implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival rates
Time Frame: 5-18 years
Survival rates of short dental implants
5-18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic: Annual bone loss
Time Frame: 5-18 years
Distance from the implant shoulder to the marginal bone.
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Plaque-index
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Sulcus bleeding index
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Probing depth
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Prosthetic reconstruction
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Implant position
5-18 years
Clinically: modifying risk factors on implant survival and success
Time Frame: 5-18 years
Crown-to-implant ratio
5-18 years
Patient reported outcome measures
Time Frame: 5-18 years
Visual analog scale (satisfaction between 0 - 100%)
5-18 years
Patient reported outcome measures
Time Frame: 5-18 years
Oral health impact profile
5-18 years
Implant success rates
Time Frame: 5-18 years
Success rates of dental implants. Success rates according to Buser et al. 1990.
5-18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Study Chair: Vivianne Chappuis, DMD, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Actual)

April 8, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

July 9, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_6mm_implants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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