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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656823
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE November 24, 2015
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
Implant survival [ Time Frame: 5 years after loading ]
Number of implants in place
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Implant survival [ Time Frame: 1 year after loading ]
    Number of implants in place
  • Implant survival [ Time Frame: 3 years after loading ]
    Number of implants in place
  • Implant survival [ Time Frame: 5 years after loading ]
    Number of implants in place
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implant-fixed Restorations With ANKYLOS 6.6 mm Implants in the Edentulous Maxilla - A 5-year Follow-up Study
Official Title  ICMJE Implant-fixed Restorations With Short Implants in the Edentulous Maxilla - A Clinical Investigation Over a 5-year Follow-up Period
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Edentulous Maxilla
Intervention  ICMJE Device: ANKYLOS C/X 6.6 mm
Study Arms  ICMJE ANKYLOS C/X 6.6 mm implants
ANKYLOS C/X 6.6 mm implants
Intervention: Device: ANKYLOS C/X 6.6 mm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
56
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT02656823
Other Study ID Numbers  ICMJE C-AN-14-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dentsply Sirona Implants
Study Sponsor  ICMJE Dentsply Sirona Implants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Weigl J. W. Goethe-Universität, Frankfurt
PRS Account Dentsply Sirona Implants
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP