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

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ClinicalTrials.gov Identifier: NCT04017026
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Bern

Brief 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.

Condition or disease Intervention/treatment
Jaw, Edentulous, Partially Dental Implant Failed Implant Complication Device: Implantation

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
Actual Study Start Date : July 20, 2016
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2019

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




Primary Outcome Measures :
  1. Implant survival rates [ Time Frame: 5-18 years ]
    Survival rates of short dental implants


Secondary Outcome Measures :
  1. Radiographic: Annual bone loss [ Time Frame: 5-18 years ]
    Distance from the implant shoulder to the marginal bone.

  2. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Plaque-index

  3. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Sulcus bleeding index

  4. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Probing depth

  5. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Prosthetic reconstruction

  6. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Implant position

  7. Clinically: modifying risk factors on implant survival and success [ Time Frame: 5-18 years ]
    Crown-to-implant ratio

  8. Patient reported outcome measures [ Time Frame: 5-18 years ]
    Visual analog scale (satisfaction between 0 - 100%)

  9. Patient reported outcome measures [ Time Frame: 5-18 years ]
    Oral health impact profile

  10. Implant success rates [ Time Frame: 5-18 years ]
    Success rates of dental implants. Success rates according to Buser et al. 1990.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Partially or fully edentulous jaw
  • Written informed consent

Exclusion Criteria:

  • Pregnant women/lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017026


Contacts
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Contact: Vivianne Chappuis, DMD vivianne.chappuis@zmk.unibe.ch

Locations
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Switzerland
Department for oral surgery of the zmk Bern, University of Bern Recruiting
Bern, Switzerland, 3010
Contact: Vivianne Chappuis, DMD       vivianne.chappuis@zmk.unibe.ch   
Sponsors and Collaborators
University of Bern
Investigators
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Study Chair: Vivianne Chappuis, DMD University of Bern

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT04017026     History of Changes
Other Study ID Numbers: 2019_6mm_implants
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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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

Keywords provided by University of Bern:
Short dental implant
Partially edentulous jaw

Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases