- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376164
Laser in Orthodontic Leveling and Alignment
May 3, 2020 updated by: Tharwat osman Mohi Eldeen Elshehawy
Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal
to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly divided into two parallel groups; a control group without laser intervention and a laser group which received LLLT.
All patients followed a non-extraction approach using one category of fixed appliance and matching conventional NiTi archwire sequence during 3 months observation period.
In laser group, mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects.
This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months.
In both groups, relief of mandibular crowding was assessed by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12 weeks (T3) intervals.
Changes in LII scores were evaluated through scanned 3D models via software.
In addition, the monthly rate of OTM was calculated and compared.
The level of significance was set at p ≤ 0.05.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11751
- Al-Azhar University
-
-
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
16 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Selection of participants was based on the following criteria:
- The age range was from 15 to 25 years.
- All permanent teeth erupted (3rd molar not included).
- Angle class I occlusion with normal facial proportions.
- Moderate crowding in the lower dental arch assessed by Little's irregularity index that requires treatment with fixed appliance using non-extraction approach.
- Good oral and general health.
- No previous or current periodontal disease.
- No systemic disease or regular medication that could interfere and\or affects orthodontic teeth movement.
- No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunction.
- No previous orthodontic treatment.
Exclusion Criteria:
The patients were excluded from the study if they have:
- Severe crowding that requires an extraction approach.
- Blocked-out teeth that didn't allow for placement of the bracket at the initial bonding appointment.
- Poor oral hygiene or periodontally compromised teeth.
- Relevant medical history that interferes with orthodontic treatment.
- Craniofacial anomalies or previous history of trauma, bruxism or parafunction.
- Previous orthodontic treatment.
- The deep bite which interferes with orthodontic brackets placement.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
was treated without laser intervention
|
|
Experimental: laser group
received low level laser therapy
|
mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects.
This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy
Time Frame: 6 Months
|
Effect of the LLLT on alignment of the mandibular anterior teeth through evaluation of changes in Little's Irregularity Index (LII) scores (mm) throughout 12 weeks observation period of the study
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: tharwat O elshehay, MSc student, Al-Azhar University
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)
January 1, 2018
Primary Completion (Actual)
June 10, 2018
Study Completion (Actual)
July 15, 2018
Study Registration Dates
First Submitted
May 2, 2020
First Submitted That Met QC Criteria
May 3, 2020
First Posted (Actual)
May 6, 2020
Study Record Updates
Last Update Posted (Actual)
May 6, 2020
Last Update Submitted That Met QC Criteria
May 3, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101 (Hamilton Integrated Research Ethics Board)
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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