Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply International
ClinicalTrials.gov Identifier:
NCT00780273
First received: October 24, 2008
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: March 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Edentulism
Interventions: Device: Ankylos Implants
Device: Biomet 3i Prevail Implants

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dental Implants.

3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.

Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.

A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.

After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.


Participant Flow:   Overall Study
    Dental Implants.  
STARTED     19  
COMPLETED     17  
NOT COMPLETED     2  
Death                 1  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dental Implants.

3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.

Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.

A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.

After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.


Baseline Measures
    Dental Implants.  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     1  
Gender  
[units: participants]
 
Female     3  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level   [ Time Frame: 6 months after surgery ]

2.  Primary:   Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level   [ Time Frame: 12 months after surgery ]

3.  Primary:   Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level   [ Time Frame: 24 months after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. George Romanos
Organization: University if Rochester Medical Center
phone: 585-276-4149
e-mail: GeorgiosRomanos@urmc.rochester.edu


No publications provided


Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT00780273     History of Changes
Other Study ID Numbers: DF 245
Study First Received: October 24, 2008
Results First Received: March 17, 2014
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board