Back to resultsEvaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
Primary Purpose
Dental Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corticotomy and low laser therapy
Corticotomy facilitated Orthodontics
Sponsored by
About this trial
This is an interventional treatment trial for Dental Malocclusion
Eligibility Criteria
Inclusion Criteria:
- Post pubertal patients with age more than 17 years.
- Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.
Exclusion Criteria:
- Patients having missing permanent canine teeth in maxillary arch.
- History of trauma or root canal treatment in maxillary canines.
- History of previous orthodontic treatment.
- History of hormonal disorder or syndrome.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Corticotomy facilitated orthodontics.
Corticotomy and low level laser therapy
Arm Description
Corticotomy is carried out under local anesthesia in right side.
Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring
Outcomes
Primary Outcome Measures
Rate of canine retraction
Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.
Secondary Outcome Measures
Root resorption
Root resorption using CBCT in mm after the end of canine retraction period (at the end of 4 months)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03906084
Brief Title
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
Official Title
Evaluation of the Combined Effect of Corticotomy and Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement: Split Mouth Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the present study was to compare, a standard efficient technique in accelerating OTM as surgical corticotomy as a gold standard versus surgical corticotomy combined with LLLT in an attempt for further acceleration of OTM.
Detailed Description
The study design was a randomized split mouth design to compare, clinically and radiographically, between the two interventions (Corticotomy and Laser versus Corticotomy only) by assessing the rate of maxillary canine retraction achieved in 4 months. Secondary outcomes were to evaluate 1st maxillary molar anchorage loss, changes in tipping, torque and rotations values of maxillary canine and 1st molar. In addition, the impact of both interventions on root resorption was assessed. The present study was carried on 16 female patients. All patients required maxillary 1st premolar extraction and subsequent maxillary canine retraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single Blind Endpoint Classification: Efficacy Study
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corticotomy facilitated orthodontics.
Arm Type
Active Comparator
Arm Description
Corticotomy is carried out under local anesthesia in right side.
Arm Title
Corticotomy and low level laser therapy
Arm Type
Experimental
Arm Description
Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring
Intervention Type
Procedure
Intervention Name(s)
Corticotomy and low laser therapy
Intervention Description
Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring
Intervention Type
Procedure
Intervention Name(s)
Corticotomy facilitated Orthodontics
Intervention Description
Corticotomy is carried out under local anesthesia in right side.
Primary Outcome Measure Information:
Title
Rate of canine retraction
Description
Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Root resorption
Description
Root resorption using CBCT in mm after the end of canine retraction period (at the end of 4 months)
Time Frame
after 4 months from start of clinical trial
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post pubertal patients with age more than 17 years.
Class I or Class II (Angles' classification) malocclusion cases requiring 1st premolar extraction with moderate anchorage.
Exclusion Criteria:
Patients having missing permanent canine teeth in maxillary arch.
History of trauma or root canal treatment in maxillary canines.
History of previous orthodontic treatment.
History of hormonal disorder or syndrome.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
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