Trial Outcomes & Findings for Efficiency of Piezotome-Corticision Assisted Orthodontics (NCT NCT02026258)
NCT ID: NCT02026258
Last Updated: 2017-08-07
Results Overview
Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Results posted on
2017-08-07
Participant Flow
Participant milestones
| Measure |
Orthodontics no Piezocision
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. Time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The de
|
|---|---|---|
|
Randomized
STARTED
|
20
|
21
|
|
Randomized
COMPLETED
|
16
|
19
|
|
Randomized
NOT COMPLETED
|
4
|
2
|
|
Recieved Allocated Intervention
STARTED
|
16
|
19
|
|
Recieved Allocated Intervention
COMPLETED
|
15
|
17
|
|
Recieved Allocated Intervention
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Orthodontics no Piezocision
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. Time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The de
|
|---|---|---|
|
Randomized
Did not start treatment
|
2
|
1
|
|
Randomized
Change in treatment plan
|
1
|
0
|
|
Randomized
Presence of periodontal disease
|
1
|
1
|
|
Recieved Allocated Intervention
Withdrawal by Subject
|
1
|
1
|
|
Recieved Allocated Intervention
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficiency of Piezotome-Corticision Assisted Orthodontics
Baseline characteristics by cohort
| Measure |
Orthodontics no Piezocision
n=13 Participants
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
n=16 Participants
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
30 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
29.7 years
STANDARD_DEVIATION 15.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Little Irrgularity at T0
|
8.32 millimeters
STANDARD_DEVIATION 2.29 • n=99 Participants
|
6.73 millimeters
STANDARD_DEVIATION 1.99 • n=107 Participants
|
7.5 millimeters
STANDARD_DEVIATION 3 • n=206 Participants
|
PRIMARY outcome
Timeframe: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 monthsDays until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.
Outcome measures
| Measure |
Orthodontics no Piezocision
n=13 Participants
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
n=16 Participants
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
|---|---|---|
|
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
|
112 Days to complete alignment
Standard Deviation 46.22
|
102.13 Days to complete alignment
Standard Deviation 34.73
|
SECONDARY outcome
Timeframe: Immediate to 1 week after wire placement (T0-T3)Specific questions questionnaire included: 1\) How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)
Outcome measures
| Measure |
Orthodontics no Piezocision
n=13 Participants
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
n=16 Participants
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
|---|---|---|
|
Questionnaires Involving Pain Level
Visual Analogue Scale (VAS) at T0 (0-100)
|
7.57 units on a scale
Standard Deviation 9.65
|
18.25 units on a scale
Standard Deviation 24.03
|
|
Questionnaires Involving Pain Level
VAS T1
|
12.55 units on a scale
Standard Deviation 13.67
|
28.74 units on a scale
Standard Deviation 25.99
|
|
Questionnaires Involving Pain Level
VAS T2
|
20.71 units on a scale
Standard Deviation 19.09
|
28.93 units on a scale
Standard Deviation 18.11
|
|
Questionnaires Involving Pain Level
VAS T3
|
8.01 units on a scale
Standard Deviation 9.06
|
11.46 units on a scale
Standard Deviation 14.50
|
SECONDARY outcome
Timeframe: 4-5 weeks after first wire placementVisual analogue Scale from 0-100 1. Are you satisfied with your treatment? Very- Not Satisfied (0-100) 2. How easy was the procedure to you? Easy-Complicated (0-100)
Outcome measures
| Measure |
Orthodontics no Piezocision
n=13 Participants
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
n=16 Participants
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
|---|---|---|
|
Questionnaire on Easiness and Satisfaction With the Procedure
Satisfaction with Procedure
|
4.31 units on a scale
Standard Deviation 8.03
|
9.08 units on a scale
Standard Deviation 18.03
|
|
Questionnaire on Easiness and Satisfaction With the Procedure
Ease of Procedure
|
7.85 units on a scale
Standard Deviation 8.79
|
9.35 units on a scale
Standard Deviation 10.41
|
SECONDARY outcome
Timeframe: 4-5 weeks after first wire placementBinomial measurement in questionnaire on medications taken and satisfaction with the procedure 1. Did you take any pain medication after the procedure? Y/N (Count Yes) 2. Would you undergo this procedure again? Y/N (Count Yes) 3. Would you recommend this procedure to a friend? Y/N (Count Yes)
Outcome measures
| Measure |
Orthodontics no Piezocision
n=13 Participants
Subjects will have orthodontic treatment without corticision with piezotome. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
Orthodontics With Piezotome Corticision
n=16 Participants
Subjects receiving orthodontic treatment in conjunction with piezotome-corticision. Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be the same as the control orthodontic group. The time taken to reach complete alignment for each patient and the rate of tooth alignment will be calculated.
Piezotome-Corticision: A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin.
Orthodontics: Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-1mm). Archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
|
|---|---|---|
|
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Use of Medications
|
8 Participants
|
11 Participants
|
|
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Undergo procedure again
|
11 Participants
|
14 Participants
|
|
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Recommend Procedure to Friend
|
13 Participants
|
14 Participants
|
Adverse Events
Orthodontics no Piezocision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Orthodontics With Piezotome Corticision
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