Trial record 2 of 30 for:    Open Studies | "Pain Perception"

Efficiency of Piezotome-Corticision Assisted Orthodontics

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Information provided by (Responsible Party):
Flavio Uribe, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT02026258
First received: December 23, 2013
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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 Intervention
Mandibular Anterior Crowding
Piezocision
Pain Perception
Procedure: Piezotome-Corticision
Device: Orthodontics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Little's irregularity index of mandibular anterior teeth [ Time Frame: From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaires involving pain level [ Time Frame: One week after wire placement and one month after wire placement ] [ Designated as safety issue: No ]

    Specific questions in the questionnaire include:

    How much pain/discomfort did you have at the following time points?

    Did you take any type of pain medication after your treatment? If yes, when? Indicate which one of the following pain killers?

    • Salicylate NSAIDs (Example: Aspirin, Diflunisal, etc.)
    • Propionic NSAIDs (Example: Ibuprofen/Motrin/Advil, Naproxen, etc.)
    • Aniline analgesic (Example: Acetaminophen/Tylenol)
    • Opioids (Example: Codeine, Hydrocodone, Morphine, etc.)
    • Combination drugs (Example: Vicodin/Acetaminophen and Hydrocodone)
    • Other

    If other, please write the name of the medication below:

    2. Are you satisfied with your treatment? 3. How easy was the procedure to you? 4. Would you undergo this procedure again? 5. Would you recommend this procedure to a friend?



Estimated Enrollment: 36
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 0-1mm). 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. 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 0-1mm). 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.
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 0-1mm). 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. 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 0-1mm). 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026258

Contacts
Contact: Leyla Davoody, DMD 860 69 2550 ldavoody@gde.uchc.edu

Locations
United States, Connecticut
Orthodontic Clinic University of Connecticut Recruiting
Farmington, Connecticut, United States, 06030
Contact: Flavio A Uribe, DDS, MDent Sc    860 679 3656    furibe@uchc.edu   
Contact: Leyla Davoody, DMD    860 679 2550    ldavoody@gde.uchc.edu   
Principal Investigator: Flavio A Uribe, DDS MDentSc         
Sub-Investigator: Khalid Almas, BDS, MSc         
Sponsors and Collaborators
University of Connecticut Health Center
  More Information

Publications:

Responsible Party: Flavio Uribe, Associate Professor, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT02026258     History of Changes
Other Study ID Numbers: IE-12-047-2
Study First Received: December 23, 2013
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014