- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906084
Evaluation of the Effect of Corticotomy and Low Level Laser Therapy on Orthodontic Tooth Movement
April 5, 2019 updated by: Karim Ahmed Farid Shehab, Cairo University
Evaluation of the Combined Effect of Corticotomy and Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement: Split Mouth Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
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
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Corticotomy facilitated orthodontics.
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
|
|
Experimental: Corticotomy and low level laser therapy
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
|
Corticotomy is carried out under local anesthesia in right side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of canine retraction
Time Frame: 4 months
|
Rate of canine retraction using a digital caliper, units of mm, readings extracted from digital models reading each month.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Root resorption
Time Frame: after 4 months from start of clinical trial
|
Root resorption using CBCT in mm after the end of canine retraction period (at the end of 4 months)
|
after 4 months from start of clinical trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 1, 2015
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
April 3, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2015-03-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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