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The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients

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ClinicalTrials.gov Identifier: NCT03646942
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

We will treat patients with class I malocclusion who have moderate crowding (4-6 mm) according to Little's irregularity index and asses the efficacy of low level laser therapy in accelerating orthodontic tooth movement .

There is two groups :

  1. treated with Low level laser therapy (LLLT)
  2. treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed.

Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .


Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class I Crowding Radiation: low level laser therapy Device: Lingual Orthodontics Not Applicable

Detailed Description:

The time of orthodontic treatment is considered to be one of the most concerns for patients. The study will investigate the effect of low level laser therapy on the speed of orthodontic tooth movement during the correction of moderately crowded anterior upper teeth using lingual orthodontic appliance.

The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention.

Low level laser with a wave length of 830 nm, output of 150 mW, energy of 2 J per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth.

Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Low-Level-LASER Therapy (LLLT) Effect on Accelerating Orthodontic Tooth Movement For Crowded Upper Incisors Leveling and Alignment in Lingual Orthodontic Patients: A Randomized Clinical Controlled Trial
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Active Comparator: Lingual orthodontics
Patients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way.
Radiation: low level laser therapy
low level laser therapy will be used in order to induce tooth movement. low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 Joules/each tooth.
Other Names:
  • LLLT
  • soft tissue laser

Device: Lingual Orthodontics
Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.

Experimental: Low level laser therapy
Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.
Radiation: low level laser therapy
low level laser therapy will be used in order to induce tooth movement. low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 Joules/each tooth.
Other Names:
  • LLLT
  • soft tissue laser




Primary Outcome Measures :
  1. Duration of tooth alignment [ Time Frame: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average ]
    Days required to complete tooth alignment will be counted.

  2. Change in Tooth Alignment at one month [ Time Frame: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment. ]

    Little's Index of Irregularity will be measured at 30 days after the onset of treatment.

    This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.


  3. Change in Tooth Alignment at two months [ Time Frame: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment. ]

    Little's Index of Irregularity will be measured at 60 days after the onset of treatment.

    This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.


  4. Change in Tooth Alignment at the end of Alignment Stage [ Time Frame: T1: one day before the beginning of treatment; T2: when alignment of teeth is complete and this is expected to occur within 90 - 120 days ]

    Little's Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.

    This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.



Secondary Outcome Measures :
  1. Change in the levels of pain and discomfort [ Time Frame: T1: 10 minutes following the insertion of the first wire in the beginning of treatment; T2: at 24 hours post-commencement; T3: at 48 hours; T4: at 72 hours following the placement of primary archwire ]
    Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment.

  2. Change in Patients' Acceptance [ Time Frame: (1) one day following the beginning of the treatment, (2) after one week of the beginning of treatment, (3) after 4 weeks, (5) at the end the alignment stage which is expected to occur within 3 to 4 months ]
    Assessment will be performed using a standardized questionnaire



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Ages Eligible for Study:   17 Years to 27 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Class I malocclusion with mild to moderate crowding
  • Old between 17-27 years
  • Good oral hygiene
  • Patients should be fit and well
  • 4-6 mm crowding in upper incisors according to Little's index
  • Enough clinical crowns length

Exclusion Criteria:

  • Patients who had an old orthodontic treatment
  • People who have any drug or disease affect orthodontic movement
  • Any contraindication for orthodontic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646942


Locations
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Syrian Arab Republic
Orthodontic Department, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Study Chair: Mohammad Y Hajeer, DDS MSc PhD Associate Professor of Orthodontics, University of Damascus Dental School, SYRIA
Principal Investigator: Wael Al-Rasheed Omer, DDS MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA
Study Director: Wael Mahdi, DDS MSc PhD Associate Professor of Periodontics, University of Damascus Dental School, Damascus, SYRIA

Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03646942     History of Changes
Other Study ID Numbers: UDDS-Ortho-08-2018
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class I
Tooth Diseases
Stomatognathic Diseases