Trial Outcomes & Findings for The Evaluation Of The Efficiency Of Micro-osteoperforation (NCT NCT03652454)
NCT ID: NCT03652454
Last Updated: 2022-10-03
Results Overview
tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
Results posted on
2022-10-03
Participant Flow
Micro-Osteoperforation, Regional Acceleration Phenomenon, Orthodontic Alignment Inclusion Criteria: * All permanent teeth have been worn (except 3rd molar) * More than 5 mm perforation compared to LII * Gingival and periodontal indices less than 1 * Good hygiene
Participant milestones
| Measure |
Micro-osteoperforation
Propel device (ABD)
micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone. The procedure was applied at the beginning of the study in the areas of crowding and not repeated.
|
Conventional Treatment
conventional fixed appliance treatment
conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation Of The Efficiency Of Micro-osteoperforation
Baseline characteristics by cohort
| Measure |
Micro-osteoperforation
n=14 Participants
Propel device (ABD)
micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel device (ABD)
micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon. Propel® is a single-use device specially produced for micro-osteoperforation. The device contains a 1.5 mm thick perforation tip. It has a depth adjustment of 3, 5 and 7 mm and the LED depth indicator gives a warning when the desired depth is reached. The device was removed from its sterile packaging and, after setting the desired depth, was gently placed on the gum and turned clockwise with a slight pressure. When the desired skin was reached, it was removed by turning counterclockwise with the LED indicator on. Micro-osteoperforations were performed directly and atraummatically in the keratinized gum from two or three points, 3 mm between canine canine, 5 mm between canine molar, and 7 mm deep in the posterior region and 1.5 mm in diameter in the alveolar bone.
|
Conventional Treatment
n=14 Participants
conventional fixed appliance treatment
conventional fixed appliance treatment: conventional fixed appliance treatment conventional fixed appliance treatment
conventional fixed appliance treatment: conventional fixed appliance treatment. Leveling with 0.014 inch nickel titanium (Ni-Ti, American Orthodontics, Sheboygan, WI, USA) arc wire was started in patients in each group using traditional fixed orthodontic bracket. All patients were invited to the controls once a month and each session was measured and a plaster model was created until the leveling phase was completed. Depending on the leveling, 0.014 inch, 0.016 inch, 0.016x0.022 inch and finally 0.019x0.025 inch Ni-Ti (American Orthodontics, Sheboygan, WI, USA) wires were used respectively. In both groups, arc wires were connected to the slots with prefabricated steel wire ligatures.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
14 participants
n=93 Participants
|
14 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
little irregularity index
|
9.99 millimetres
STANDARD_DEVIATION 2.63 • n=93 Participants
|
8.87 millimetres
STANDARD_DEVIATION 1.5 • n=4 Participants
|
9.42 millimetres
STANDARD_DEVIATION 2.17 • n=27 Participants
|
PRIMARY outcome
Timeframe: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)Population: * All permanent teeth have been erupted (except the 3rd molars) * Presence of more than 5 mm crowding in the lower arc according to Little irregularity index * Gingival and periodontal indices less than 1 * Good oral hygiene * Patient and / or guardian volunteering to participate in the study
tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.
Outcome measures
| Measure |
Micro-osteoperforation
n=14 Participants
Propel device (ABD)
micro-osteoperforation: Propel device (ABD) using for regional acceleratory phenomenon
|
Conventional Treatment
n=14 Participants
conventional fixed appliance treatment
conventional fixed appliance treatment: conventional fixed appliance treatment
|
|---|---|---|
|
Rate of Mandibular Teeth Alignment
first month
|
4.27 millimeter (mm)
Standard Deviation 1.75
|
2.82 millimeter (mm)
Standard Deviation 0.87
|
|
Rate of Mandibular Teeth Alignment
second months
|
2.08 millimeter (mm)
Standard Deviation 0.91
|
2.31 millimeter (mm)
Standard Deviation 1.29
|
|
Rate of Mandibular Teeth Alignment
third months
|
1.94 millimeter (mm)
Standard Deviation 0.99
|
1.54 millimeter (mm)
Standard Deviation 0.65
|
|
Rate of Mandibular Teeth Alignment
fourth months
|
0.84 millimeter (mm)
Standard Deviation 0.95
|
0.89 millimeter (mm)
Standard Deviation 0.49
|
|
Rate of Mandibular Teeth Alignment
fifth months
|
0.34 millimeter (mm)
Standard Deviation 0.57
|
0.93 millimeter (mm)
Standard Deviation 0.7
|
Adverse Events
Micro-osteoperforation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Treatment
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