Trial Outcomes & Findings for Performance of MicroTextured Dental Implants (NCT NCT01821417)
NCT ID: NCT01821417
Last Updated: 2017-03-16
Results Overview
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Implant insertion, 12 months post-insertion
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
Microtextured Dental Implant
Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
Dental Implant
Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
31
|
|
Overall Study
COMPLETED
|
37
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of MicroTextured Dental Implants
Baseline characteristics by cohort
| Measure |
Microtextured Dental Implant
n=37 Participants
Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
Dental Implant
n=31 Participants
Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Greater than 19 years
|
37 participants
n=5 Participants
|
31 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
31 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant insertion, 12 months post-insertionUsing radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Outcome measures
| Measure |
Microtextured Dental Implant
n=37 Participants
Randomized for microtextured dental implant treatment
Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
Dental Implant
n=31 Participants
Randomized dental implant treatment with machined-collar implants
Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
|
|---|---|---|
|
Change in Millimeters of Bone Loss Surrounding the Implant Device
|
-0.35 millimeters
Standard Deviation 0.56
|
-0.82 millimeters
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 1 year after placementPopulation: No data was collected. Previously entered data was entered incorrectly.
Measurement of changes in peri-implant gingivitis score \[Loe and Silness gingival index (GI)\] after implant restoration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year after placementPopulation: No data was collected. Previously entered data was entered incorrectly.
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
Outcome measures
Outcome data not reported
Adverse Events
Microtextured Dental Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dental Implant
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
Nicolaas C. Geurs, DDS MS
University of Alabama at Birmingham
Phone: 2059344506
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place