Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-01 @ 12:29 PM
Study NCT ID:
NCT02026258
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2013-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficiency of Piezotome-Corticision Assisted Orthodontics
Sponsor:
UConn Health
Organization:
Study Overview
Official Title:
Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: