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Trial record 1 of 1 for:    NCT02026258
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Efficiency of Piezotome-Corticision Assisted Orthodontics

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ClinicalTrials.gov Identifier: NCT02026258
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Flavio Uribe, UConn Health

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Mandibular Anterior Crowding Piezocision Pain Perception Procedure: Piezotome-Corticision Device: Orthodontics Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial
Study Start Date : December 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Device: 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.
Experimental: 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 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.
 Procedure: 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 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.

Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index [ Time Frame: 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 :
  1. Questionnaires Involving Pain Level [ Time Frame: 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)


  2. Questionnaire on Easiness and Satisfaction With the Procedure [ Time Frame: 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)

  3. Questionnaire Involving Pain Management and Satisfaction With the Procedure [ Time Frame: 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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026258


Locations
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United States, Connecticut
Orthodontic Clinic University of Connecticut
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Flavio Uribe, DDS MDS UConn Health
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Buschang PH, Campbell PM, Ruso S. Accelerating tooth movement with corticotomies: is it possible and desirable? Semin Orthod 2012;18:286-294.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Flavio Uribe, Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02026258    
Other Study ID Numbers: IE-12-047-2
First Posted: January 1, 2014    Key Record Dates
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes