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Completed

NCT Number: NCT02026258

Efficiency of Piezotome-Corticision Assisted Orthodontics

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.

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Key information

Conditions

Mandibular Anterior Crowding Pain Perception Piezocision

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Clinic University of Connecticut

Farmington, Connecticut, 06030, United States

About this study

This study will specifically try:

  • To compare the time required to achieve complete alignment of crowded mandibular anterior teeth (canine to canine) between piezotome-corticision assisted and conventional orthodontics.
  • 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.
  • 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

  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piezotome-Corticision

Procedure

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.

Orthodontics

Device

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.

Primary outcomes

  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 outcomes

  1. Questionnaires Involving Pain Level

    Time frame: Immediate to 1 week after wire placement (T0-T3)

    Specific questions questionnaire included:

    • 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

    • Are you satisfied with your treatment? Very- Not Satisfied (0-100)
    • 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

    • Did you take any pain medication after the procedure? Y/N (Count Yes)
    • Would you undergo this procedure again? Y/N (Count Yes)
    • Would you recommend this procedure to a friend? Y/N (Count Yes)

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2014
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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