Clinical trial NCT02026258: Efficiency of Piezotome-Corticision Assisted Orthodontics
Official title: Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Anterior Crowding
Piezocision
Pain Perception
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index
timeFrame: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months
Secondary outcomes:
measure: Questionnaires Involving Pain Level
timeFrame: Immediate to 1 week after wire placement (T0-T3)
measure: Questionnaire on Easiness and Satisfaction With the Procedure
timeFrame: 4-5 weeks after first wire placement
measure: Questionnaire Involving Pain Management and Satisfaction With the Procedure
timeFrame: 4-5 weeks after first wire placement
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Orthodontic Clinic University of Connecticut
state: Connecticut
Study officials:
affiliation: UConn Health
name: Flavio Uribe, DDS MDS
role: PRINCIPAL_INVESTIGATOR
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