Mandibular Anterior Crowding, Pain Perception, Piezocision
Conditions
Brief summary
The aim of this study is to evaluate the hypothesis that a piezotome-corticision procedure will have a transient acceleratory effect on the rate of tooth alignment and the overall treatment time. In addition, the subjects in the piezotome-corticision orthodontics group will experience a different level of pain, comfort, and satisfaction as opposed to the conventional orthodontics group.
Detailed description
This study will specifically try: 1. To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics. 2. To investigate the rate of alignment of mandibular anterior teeth at different time points until complete alignment is achieved using dental casts taken at every visit. 3. To compare subject's perception of pain, comfort and satisfaction between the piezotome-corticision assisted and conventional orthodontics using two questionnaires. Eligibility criteria includes: * Adult patients 18 or older * Single arch or double arch treatment * Non-extraction treatment in the mandibular arch * Presence of full complement dentition from first molar to first molar * No spaces in the mandibular arch * Mandibular anterior irregularity index greater than 5 * Patient with healthy periodontium and attachment loss of up to 2mm * The amount of crowding should allow for bracket placement * No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth. Exclusion criteria includes: * Failure to provide oral and written consent to participation * Medical problems that affect tooth movement (Refer to Appendix I) * Presence of primary teeth in the mandibular anterior area * Missing permanent mandibular anterior teeth * Inability to place brackets in the anterior mandibular teeth * Breakage of any of the mandibular anterior brackets that have not been replaced within a week Outcome measures 1. Two outcome assessors will be calibrated in the assessment of the Little's irregularity index. The irregularity index will be measured twice by two blinded outcome assessors using a fine-tip digital caliper. 2. The subjects will be instructed to record their level of pain: immediately, 1 hour, 12 hours, and 7 days after the first wire placement \[76, 82\]. They will be also asked to report if they had taken any pain medications, their level of ease and satisfaction with the procedure, if they would undergo this procedure again, and if they would recommend it to a friend. A 100 mm Visual Analog Scale (VAS) will be used to evaluate the level of pain, ease, and satisfaction of all the subjects, with anchors at each end of the line that read no pain (easy, satisfied) (0 mm) and most pain (complicated, not satisfied) (100 mm).
Interventions
PROCEDUREPiezotome-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 depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed.
DEVICEOrthodontics
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.
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients 18 or older * Single arch or double arch treatment * Non-extraction treatment in the mandibular arch * Presence of full complement dentition from first molar to first molar * No spaces in the mandibular arch * Mandibular anterior irregularity index greater than 5 * Patient with healthy periodontium and attachment loss of up to 2mm * The amount of crowding should allow for bracket placement * No therapeutic intervention planned involving intermaxillary or other intraoral or extraoral appliances including elastics, lip bumpers, maxillary expansion appliances, or headgear prior to the complete alignment of mandibular anterior teeth.
Exclusion criteria
* Failure to provide oral and written consent to participation * Medical problems that affect tooth movement (Refer to Appendix I) * Presence of primary teeth in the mandibular anterior area * Missing permanent mandibular anterior teeth * Inability to place brackets in the anterior mandibular teeth * Breakage of any of the mandibular anterior brackets that have not been replaced within a week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index | From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaires Involving Pain Level | 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) |
| Questionnaire on Easiness and Satisfaction With the Procedure | 4-5 weeks after first wire placement | Visual 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) |
| Questionnaire Involving Pain Management and Satisfaction With the Procedure | 4-5 weeks after first wire placement | Binomial 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 0-2mm). 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. | 13 |
| 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 0-2mm). 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. | 16 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomized | Change in treatment plan | 1 | 0 |
| Randomized | Did not start treatment | 2 | 1 |
| Randomized | Presence of periodontal disease | 1 | 1 |
| Recieved Allocated Intervention | Lost to Follow-up | 0 | 1 |
| Recieved Allocated Intervention | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Orthodontics no Piezocision | Orthodontics With Piezotome Corticision | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 9.3 | 30 years STANDARD_DEVIATION 12.5 | 29.7 years STANDARD_DEVIATION 15.5 |
| Little Irrgularity at T0 | 8.32 millimeters STANDARD_DEVIATION 2.29 | 6.73 millimeters STANDARD_DEVIATION 1.99 | 7.5 millimeters STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 13 participants | 16 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 19 |
| other Total, other adverse events | 0 / 16 | 0 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
Primary
Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
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.
Time frame: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthodontics no Piezocision | 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 |
| Orthodontics With Piezotome Corticision | Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index | 102.13 Days to complete alignment | Standard Deviation 34.73 |
Comparison: Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Questionnaire Involving Pain Management and Satisfaction With the Procedure
Binomial 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)
Time frame: 4-5 weeks after first wire placement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Orthodontics no Piezocision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Use of Medications | 8 Participants |
| Orthodontics no Piezocision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Undergo procedure again | 11 Participants |
| Orthodontics no Piezocision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Recommend Procedure to Friend | 13 Participants |
| Orthodontics With Piezotome Corticision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Use of Medications | 11 Participants |
| Orthodontics With Piezotome Corticision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Undergo procedure again | 14 Participants |
| Orthodontics With Piezotome Corticision | Questionnaire Involving Pain Management and Satisfaction With the Procedure | Recommend Procedure to Friend | 14 Participants |
p-value: <0.05Fisher Exact
Comparison: Undergo procedure againp-value: <0.05Fisher Exact
Comparison: Recommend procedure to a friendp-value: <0.05Fisher Exact
Secondary
Questionnaire on Easiness and Satisfaction With the Procedure
Visual 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)
Time frame: 4-5 weeks after first wire placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthodontics no Piezocision | Questionnaire on Easiness and Satisfaction With the Procedure | Ease of Procedure | 7.85 units on a scale | Standard Deviation 8.79 |
| Orthodontics no Piezocision | Questionnaire on Easiness and Satisfaction With the Procedure | Satisfaction with Procedure | 4.31 units on a scale | Standard Deviation 8.03 |
| Orthodontics With Piezotome Corticision | Questionnaire on Easiness and Satisfaction With the Procedure | Ease of Procedure | 9.35 units on a scale | Standard Deviation 10.41 |
| Orthodontics With Piezotome Corticision | Questionnaire on Easiness and Satisfaction With the Procedure | Satisfaction with Procedure | 9.08 units on a scale | Standard Deviation 18.03 |
Comparison: Ease of Procedurep-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: Satisfaction with procedurep-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Questionnaires Involving Pain Level
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)
Time frame: Immediate to 1 week after wire placement (T0-T3)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthodontics no Piezocision | Questionnaires Involving Pain Level | Visual Analogue Scale (VAS) at T0 (0-100) | 7.57 units on a scale | Standard Deviation 9.65 |
| Orthodontics no Piezocision | Questionnaires Involving Pain Level | VAS T1 | 12.55 units on a scale | Standard Deviation 13.67 |
| Orthodontics no Piezocision | Questionnaires Involving Pain Level | VAS T2 | 20.71 units on a scale | Standard Deviation 19.09 |
| Orthodontics no Piezocision | Questionnaires Involving Pain Level | VAS T3 | 8.01 units on a scale | Standard Deviation 9.06 |
| Orthodontics With Piezotome Corticision | Questionnaires Involving Pain Level | VAS T3 | 11.46 units on a scale | Standard Deviation 14.5 |
| Orthodontics With Piezotome Corticision | Questionnaires Involving Pain Level | Visual Analogue Scale (VAS) at T0 (0-100) | 18.25 units on a scale | Standard Deviation 24.03 |
| Orthodontics With Piezotome Corticision | Questionnaires Involving Pain Level | VAS T2 | 28.93 units on a scale | Standard Deviation 18.11 |
| Orthodontics With Piezotome Corticision | Questionnaires Involving Pain Level | VAS T1 | 28.74 units on a scale | Standard Deviation 25.99 |
Comparison: VAS T0p-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: VAS T1p-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: VAS T2p-value: <0.05Wilcoxon (Mann-Whitney)
Comparison: VAS T3p-value: <0.05Wilcoxon (Mann-Whitney)