Efficiency of Piezotome-Corticision Assisted Orthodontics

Not Applicable

Completed

Conditions: Pain Perception
Piezocision
Mandibular Anterior Crowding

Interventions: Device: Orthodontics
Procedure: Piezotome-Corticision

Registration Number: NCT02026258

Lead Sponsor: UConn Health

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthodontics no piezocision	Orthodontics	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 with piezotome corticision	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 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 with piezotome corticision	Orthodontics	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 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)