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Trial record 7 of 7 for:    Prevail AND delivery system

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

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ClinicalTrials.gov Identifier: NCT00780273
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Dentsply International

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Edentulism
Interventions Device: Ankylos Implants
Device: Biomet 3i Prevail Implants
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dental Implants.
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 19
Completed 17
Not Completed 2
Reason Not Completed
Death             1
Lost to Follow-up             1
Arm/Group Title Dental Implants.
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  94.7%
>=65 years
1
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
3
  15.8%
Male
16
  84.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Hide Description Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame 6 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankylos Dental Implants. 3i Prevail Dental Implants.
Hide Arm/Group Description:

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

Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.

Biomet 3i Prevail Implants

Overall Number of Participants Analyzed 19 19
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
52 53
Measure Type: Number
Unit of Measure: Percentage of implants
13 55
2.Primary Outcome
Title Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Hide Description Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame 12 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankylos Dental Implants. 3i Prevail Dental Implants.
Hide Arm/Group Description:

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

Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.

Biomet 3i Prevail Implants

Overall Number of Participants Analyzed 19 19
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
49 50
Measure Type: Number
Unit of Measure: Percentage of implants
20 56
3.Primary Outcome
Title Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Hide Description Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time Frame 24 months after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ankylos Dental Implants. 3i Prevail Dental Implants.
Hide Arm/Group Description:

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

Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.

Biomet 3i Prevail Implants

Overall Number of Participants Analyzed 19 19
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
44 47
Measure Type: Number
Unit of Measure: Percentage of implants
11 70
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dental Implants.
Hide Arm/Group Description

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.

All-Cause Mortality
Dental Implants.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dental Implants.
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dental Implants.
Affected / at Risk (%)
Total   0/19 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. George Romanos
Organization: University if Rochester Medical Center
Phone: 585-276-4149
EMail: GeorgiosRomanos@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT00780273     History of Changes
Other Study ID Numbers: DF 245
First Submitted: October 24, 2008
First Posted: October 27, 2008
Results First Submitted: March 17, 2014
Results First Posted: August 19, 2014
Last Update Posted: August 19, 2014