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Effect of Low Level Laser on Orthodontic Canine Retraction

Primary Purpose

Dental Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Level Laser Therapy
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring Low Level Laser Therapy, Orthodontic Tooth movement, Canine Retraction, Two Protocols and Energy Doses

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Complete permanent dentition (3rd molars excluded).
  • The age was ranged from 15 -25 years.
  • Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction.
  • Good oral hygiene and periodontal health.

Exclusion Criteria:

  • Patients who diagnosed to have an indication for non-extraction approach.
  • Serious systemic diseases and/or long term medications that could interfere with OTM.
  • Previous orthodontic treatment.
  • Poor oral hygiene or periodontally compromised patients.
  • Craniofacial anomalies or history of parafunctional habits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Buccal &palatal low level laser therapy

    Buccal low level laser therapy

    Arm Description

    In group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.

    In group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.

    Outcomes

    Primary Outcome Measures

    Evaluation the rate of maxillary canine retraction
    Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models

    Secondary Outcome Measures

    Evaluation of anchorage loss
    Evaluation and comparison of the amount of maxillary molar mesial movement (anchorage loss) between both groups via study models assessment.

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    May 6, 2020
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04381442
    Brief Title
    Effect of Low Level Laser on Orthodontic Canine Retraction
    Official Title
    Consequence of Two Protocols and Energy Doses of Low Level Laser Therapy on the Rate of Orthodontic Canine Retraction: A Prospective Clinical Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    June 10, 2018 (Actual)
    Study Completion Date
    February 24, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    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
    The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement.
    Detailed Description
    Fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years were included. They had a clinical indication for bilateral extraction of at least first maxillary premolars. Using a split mouth design, maxillary left and right sides were randomly divided into two groups. In group 1, LLLT was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. In group II, laser was applied from buccal side only at 5 points through the same order with a dose of 4 J per session. In both protocols, maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point. Both sides were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring. In both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Amount and monthly rate of maxillary canine retraction and degree of anchorage loss were determined by direct intraoral and indirect 3D digital models measurements. Evaluations were undertaken immediately before initiating retraction (T0), after 4 weeks (T1), after 8 weeks (T2), after 12 weeks (T3), after 16 weeks (T4), after 20 weeks (T5), and after 24 weeks (T6). Significance level 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, Canine Retraction, Two Protocols and Energy Doses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Buccal &palatal LLLT Group, Buccal &palatal LLLT Group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Buccal &palatal low level laser therapy
    Arm Type
    Experimental
    Arm Description
    In group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.
    Arm Title
    Buccal low level laser therapy
    Arm Type
    Active Comparator
    Arm Description
    In group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase.
    Intervention Type
    Radiation
    Intervention Name(s)
    Low Level Laser Therapy
    Other Intervention Name(s)
    Photobiomodulation
    Primary Outcome Measure Information:
    Title
    Evaluation the rate of maxillary canine retraction
    Description
    Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Evaluation of anchorage loss
    Description
    Evaluation and comparison of the amount of maxillary molar mesial movement (anchorage loss) between both groups via study models assessment.
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Complete permanent dentition (3rd molars excluded). The age was ranged from 15 -25 years. Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction. Good oral hygiene and periodontal health. Exclusion Criteria: Patients who diagnosed to have an indication for non-extraction approach. Serious systemic diseases and/or long term medications that could interfere with OTM. Previous orthodontic treatment. Poor oral hygiene or periodontally compromised patients. Craniofacial anomalies or history of parafunctional habits.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdullah M Al-Haj, MSc student
    Organizational Affiliation
    Al-Azhar University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Farouk A Hussein, Ass.Prof
    Organizational Affiliation
    Al-Azhar University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Effect of Low Level Laser on Orthodontic Canine Retraction

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