Back to resultsLaser in Orthodontic Leveling and Alignment
Primary Purpose
Dental Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dental Malocclusion focused on measuring Low-level laser therapy, Orthodontic Tooth Movement, Leveling and Alignment, Little Irregularity Index.
Eligibility Criteria
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.
Sites / Locations
- Al-Azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
laser group
Arm Description
was treated without laser intervention
received low level laser therapy
Outcomes
Primary Outcome Measures
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04376164
First Posted
May 2, 2020
Last Updated
May 3, 2020
Sponsor
Tharwat osman Mohi Eldeen Elshehawy
1. Study Identification
Unique Protocol Identification Number
NCT04376164
Brief Title
Laser in Orthodontic Leveling and Alignment
Official Title
Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tharwat osman Mohi Eldeen Elshehawy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
Keywords
Low-level laser therapy, Orthodontic Tooth Movement, Leveling and Alignment, Little Irregularity Index.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control group laser group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
was treated without laser intervention
Arm Title
laser group
Arm Type
Experimental
Arm Description
received low level laser therapy
Intervention Type
Radiation
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
photobiomodulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy
Description
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
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tharwat O elshehay, MSc student
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar university
City
Cairo
ZIP/Postal Code
11751
Country
Egypt
12. IPD Sharing Statement
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Laser in Orthodontic Leveling and Alignment
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