Trial Outcomes & Findings for Gingival Crevicular Fluid Characterization During Orthodontic Treatment (NCT NCT04226469)
NCT ID: NCT04226469
Last Updated: 2025-05-07
Results Overview
The distance of tooth movement from initial timepoint to the end of study
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
7 weeks
Results posted on
2025-05-07
Participant Flow
Participant milestones
| Measure |
Subjects Require Canine Retraction
Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.
Tooth movement: The subject's canines will be retracted distally and crevicular fluid is collected
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gingival Crevicular Fluid Characterization During Orthodontic Treatment
Baseline characteristics by cohort
| Measure |
Subjects Require Canine Retraction
n=15 Participants
Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.
Tooth movement: The subject's canines will be retracted distally and crevicular fluid is collected
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: the distance of canine movement distally
The distance of tooth movement from initial timepoint to the end of study
Outcome measures
| Measure |
Subjects Require Canine Retraction
n=15 Participants
Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.
Tooth movement: The subject's canines will be retracted distally and crevicular fluid is collected
|
|---|---|
|
The Distance of Tooth Movement
|
5 millimeters
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: the expression of microRNAs in gingival crevicular fluid in healthy individuals who required orthodontic tooth movement with canine retraction.
The fold change of secretory microRNA expression compared to the initial level
Outcome measures
| Measure |
Subjects Require Canine Retraction
n=12 Participants
Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.
Tooth movement: The subject's canines will be retracted distally and crevicular fluid is collected
|
|---|---|
|
The Fold Change of Secretory microRNA Expression
|
5 fold change
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: volume of crevicular fluid
the volume of crevicular fluid during the tooth movement
Outcome measures
| Measure |
Subjects Require Canine Retraction
n=12 Participants
Subjects require canine retraction during orthodontic tooth movement and their gingival crevicular fluid is collected during the tooth movement. The control is the initial timepoint.
Tooth movement: The subject's canines will be retracted distally and crevicular fluid is collected
|
|---|---|
|
The Amount of Crevicular Fluid
|
75 microliteres
Standard Deviation 30
|
Adverse Events
Subjects Require Canine Retraction
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