Efficiency of Piezotome-Corticision Assisted Orthodontics
NCT ID: NCT02026258
Last Updated: 2017-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2011-12-31
2016-01-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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UConn Health
OTHER
Responsible Party
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Flavio Uribe
Associate Professor
Principal Investigators
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Flavio Uribe, DDS MDS
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Locations
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Orthodontic Clinic University of Connecticut
Farmington, Connecticut, United States
Countries
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References
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Other Identifiers
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IE-12-047-2
Identifier Type: -
Identifier Source: org_study_id
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