Trial Outcomes & Findings for Temporary Anchorage Devices for Ridge Preservation (NCT NCT03205800)
NCT ID: NCT03205800
Last Updated: 2025-02-19
Results Overview
the distance from the buccal plate to the palatal plate
COMPLETED
NA
6 participants
8 months
2025-02-19
Participant Flow
The study protocol was approved in October 2017 by the IRB. The recruitment period was from 1/12/2018 to 12/10/2018 at the University of Maryland Dental Clinics.
There was no significant event in this study that occur after participant enrollment and prior to assignment. One participant has both experimental (mini-screw placement) and control (no treatment) sides.
Unit of analysis: extraction site
Participant milestones
| Measure |
Mini-screw Placement
One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side.
Mini-screw: Placement of a mini-screw
|
No Treatment
No treatment will be conducted for extraction sockets on the contralateral side.
|
|---|---|---|
|
Overall Study
STARTED
|
3 6
|
3 6
|
|
Overall Study
COMPLETED
|
3 6
|
3 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mini-screw Placement
n=6 Teeth
One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side.
Mini-screw: Placement of a mini-screw
|
No Treatment
n=6 Teeth
No treatment will be conducted for the extraction site on the contralateral side.
|
Total
n=12 Teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 21 • n=3 Participants
|
37 years
STANDARD_DEVIATION 21 • n=3 Participants
|
37 years
STANDARD_DEVIATION 21 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Width of extraction site (ridge)
|
13.7 mm
STANDARD_DEVIATION 1.2 • n=3 Participants
|
13 mm
STANDARD_DEVIATION 1.96 • n=3 Participants
|
13.36 mm
STANDARD_DEVIATION 1.6 • n=6 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: A total of six participants (four females and two males) completed this pilot study. Their mean age was 37 ± 21 years (range, 22-68).
the distance from the buccal plate to the palatal plate
Outcome measures
| Measure |
Mini-screw Placement
n=6 Teeth
One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side.
Mini-screw: Placement of a mini-screw
|
No Treatment
n=6 Teeth
No treatment will be conducted for the extraction site on the contralateral side.
|
|---|---|---|
|
Changes in Width of Extraction Site (Ridge)
|
0.7 mm
Standard Deviation 0.2
|
1.3 mm
Standard Deviation 0.7
|
Adverse Events
Mini-screw Placement
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mini-screw Placement
n=3 participants at risk
One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side.
Mini-screw: Placement of a mini-screw
|
No Treatment
n=3 participants at risk
No treatment after tooth extraction
|
|---|---|---|
|
Infections and infestations
Inflammation at site
|
0.00%
0/3 • 8 months
|
0.00%
0/3 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place