Efficiency of Piezotome-Corticision Assisted Orthodontics

July 31, 2017 updated by: Flavio Uribe, UConn Health

Efficiency of Piezotome-Corticision Assisted Orthodontics in Alleviating Mandibular Anterior Crowding - A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Orthodontic Clinic University of Connecticut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediate to 1 week after wire placement (T0-T3)
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)
4-5 weeks after first wire placement
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)
4-5 weeks after first wire placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Investigators

  • Principal Investigator: Flavio Uribe, DDS MDS, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (ESTIMATE)

January 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IE-12-047-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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