Trial Outcomes & Findings for Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus (NCT NCT00933491)
NCT ID: NCT00933491
Last Updated: 2015-11-04
Results Overview
Mean radiographic bone level at 12 months
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
12 months
Results posted on
2015-11-04
Participant Flow
Participant milestones
| Measure |
Diabetic
Type II Diabetes
|
Control
Non-diabetics
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
14
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk Factors for Implant Bone Loss in Patients With Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Diabetic
n=14 Participants
Type II Diabetes
|
Control
n=18 Participants
Non-diabetics
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
64 years
n=7 Participants
|
64.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMean radiographic bone level at 12 months
Outcome measures
| Measure |
Diabetic
n=14 Participants
Type II Diabetes
|
Control
n=18 Participants
Non-diabetics
|
|---|---|---|
|
Radiographic Bone Level
|
2.69 mm
Standard Deviation .17
|
2.54 mm
Standard Deviation .15
|
PRIMARY outcome
Timeframe: BaselineMean radiographic bone level at baseline
Outcome measures
| Measure |
Diabetic
n=14 Participants
Type II Diabetes
|
Control
n=18 Participants
Non-diabetics
|
|---|---|---|
|
Radiographic Bone Level
|
2.59 mm
Standard Deviation .15
|
2.71 mm
Standard Deviation .14
|
Adverse Events
Diabetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place