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Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study

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ClinicalTrials.gov Identifier: NCT02656823
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief Summary:
Multicenter study to assess the survival and the success rates of six short implants (ANKYLOS C/X 6.6 mm) in the edentulous maxilla supporting fixed full-arch bridges after 5 years in function.

Condition or disease Intervention/treatment Phase
Edentulous Maxilla Device: ANKYLOS C/X 6.6 mm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : June 30, 2022

Arm Intervention/treatment
ANKYLOS C/X 6.6 mm implants
ANKYLOS C/X 6.6 mm implants
Device: ANKYLOS C/X 6.6 mm



Primary Outcome Measures :
  1. Implant survival [ Time Frame: 5 years after loading ]
    Number of implants in place



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

For inclusion in the study subjects must meet all of the following criteria:

  1. Aged 18-80 years at inclusion
  2. Signed informed consent
  3. In need of full-arch restoration of the maxilla

    The following should be considered at inclusion but need to be fulfilled at Implant Placement (Visit 3):

  4. Maxilla: totally edentulous, fulfilling all of the following criteria:

    • History of edentulism: ≥ 6 months and
    • Minimum bone height: ≥ 7 mm and
    • Minimum bone width: ≥ 5.5 mm
  5. Mandible: antagonistic natural dentition or tooth/implant borne rehabilitation which can be used to create a stable occlusal fit with the new full-arch restoration of the upper jaw

EXCLUSION CRITERIA

Any of the following is regarded as a criterion for exclusion from the study:

  1. Unlikely to be able to comply with study procedures according to Investigators judgement
  2. History of bone augmentation in the maxilla within 6 months prior to surgery
  3. Uncontrolled pathologic processes in the oral cavity
  4. Bruxism
  5. Smoking >10 cigarettes per day
  6. Present alcohol or drug abuse
  7. History of radiation therapy in head and neck region
  8. History of chemotherapy within 5 years prior to surgery
  9. Condition that would compromise post-operative tissue healing or osseointegration
  10. Bisphosphonates or any other medication that would compromise post-operative healing or osseointegration.
  11. Known pregnancy at time of inclusion
  12. Current or former participation in a clinical study that may interfere with the present study
  13. Involvement in the planning and conduct of the study

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): NCT02656823


Locations
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United States, Florida
Nova Southeastern University
Fort Lauderdale, Florida, United States
Germany
Goethe University Frankfurt
Frankfurt, Germany
Albert-Ludwigs University Freiburg
Freiburg, Germany
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
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Principal Investigator: Paul Weigl J. W. Goethe-Universität, Frankfurt

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Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT02656823     History of Changes
Other Study ID Numbers: C-AN-14-001
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Dentsply Sirona Implants:
ANKYLOS
Simplant
maxilla
edentulous
short implants

Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases