Trial Outcomes & Findings for Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses (NCT NCT00780273)
NCT ID: NCT00780273
Last Updated: 2014-08-19
Results Overview
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
6 months after surgery
Results posted on
2014-08-19
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Baseline characteristics by cohort
| Measure |
Dental Implants.
n=19 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after surgeryIncidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Outcome measures
| Measure |
Ankylos Dental Implants.
n=52 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
|
3i Prevail Dental Implants.
n=53 Implants
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
|
|---|---|---|
|
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
|
13 Percentage of implants
|
55 Percentage of implants
|
PRIMARY outcome
Timeframe: 12 months after surgeryIncidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Outcome measures
| Measure |
Ankylos Dental Implants.
n=49 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
|
3i Prevail Dental Implants.
n=50 Implants
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
|
|---|---|---|
|
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
|
20 Percentage of implants
|
56 Percentage of implants
|
PRIMARY outcome
Timeframe: 24 months after surgeryIncidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Outcome measures
| Measure |
Ankylos Dental Implants.
n=44 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
|
3i Prevail Dental Implants.
n=47 Implants
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
|
|---|---|---|
|
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
|
11 Percentage of implants
|
70 Percentage of implants
|
Adverse Events
Dental Implants.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. George Romanos
University if Rochester Medical Center
Phone: 585-276-4149
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place