Efficiency of Piezotome-Corticision Assisted Orthodontics

NCT02026258 | Completed Results DMC

• 1 other identifier: IE-12-047-2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Anterior Crowding; Piezocision; Pain Perception

Outcome Measures

Primary Outcomes (1)

• Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index

  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 Outcomes (3)

• Questionnaires Involving Pain Level

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

• Questionnaire on Easiness and Satisfaction With the Procedure

  4-5 weeks after first wire placement

• Questionnaire Involving Pain Management and Satisfaction With the Procedure

  4-5 weeks after first wire placement

Study Arms (2)

Orthodontics no piezocision

ACTIVE COMPARATOR

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

Orthodontics with piezotome corticision

EXPERIMENTAL

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; Device: Orthodontics

Interventions

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 with piezotome corticision

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.

Orthodontics no piezocision; Orthodontics with piezotome corticision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

Orthodontic Clinic University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Related Publications (34)

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  PMID: 28371882 DERIVED

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Limitations and Caveats

Hi attrition rate

Results Point of Contact

• Title: Flavio Uribe
• Organization: UConn Health

furibe@uchc.edu

8606793656

Study Officials

• Flavio Uribe, DDS MDS

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 7, 2017
• Results First Posted: August 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)