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

Primary Purpose

Malocclusion, Angle Class I, Crowding

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
low level laser therapy
Lingual Orthodontics
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

17 Years - 27 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthodontic Department, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lingual orthodontics

Low level laser therapy

Arm Description

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.

Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.

Outcomes

Primary Outcome Measures

Duration of tooth alignment
Days required to complete tooth alignment will be counted.
Change in Tooth Alignment at one month
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.
Change in Tooth Alignment at two months
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.
Change in Tooth Alignment at the end of Alignment Stage
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

Change in the levels of pain and discomfort
Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment.
Change in Patients' Acceptance
Assessment will be performed using a standardized questionnaire

Full Information

First Posted
August 22, 2018
Last Updated
July 16, 2019
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03646942
Brief Title
The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 : treated with Low level laser therapy (LLLT) 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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class I, Crowding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lingual orthodontics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low level laser therapy
Arm Type
Experimental
Arm Description
Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces.
Intervention Type
Radiation
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
LLLT, soft tissue laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lingual Orthodontics
Intervention Description
Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.
Primary Outcome Measure Information:
Title
Duration of tooth alignment
Description
Days required to complete tooth alignment will be counted.
Time Frame
When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
Title
Change in Tooth Alignment at one month
Description
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.
Time Frame
T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.
Title
Change in Tooth Alignment at two months
Description
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.
Time Frame
T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.
Title
Change in Tooth Alignment at the end of Alignment Stage
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in the levels of pain and discomfort
Description
Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment.
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
Title
Change in Patients' Acceptance
Description
Assessment will be performed using a standardized questionnaire
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, SYRIA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wael Al-Rasheed Omer, DDS
Organizational Affiliation
MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wael Mahdi, DDS MSc PhD
Organizational Affiliation
Associate Professor of Periodontics, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Department, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27869476
Citation
AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21. Erratum In: Angle Orthod. 2018 Jan;88(1):125.
Results Reference
background
PubMed Identifier
23075062
Citation
Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
Results Reference
background
PubMed Identifier
12132310
Citation
Fritz U, Diedrich P, Wiechmann D. Lingual technique--patients' characteristics, motivation and acceptance. Interpretation of a retrospective survey. J Orofac Orthop. 2002 May;63(3):227-33. doi: 10.1007/s00056-002-0124-3. English, German.
Results Reference
background
PubMed Identifier
25072362
Citation
Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.
Results Reference
background
PubMed Identifier
15334614
Citation
Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
Results Reference
background
PubMed Identifier
25332914
Citation
Camacho AD, Velasquez Cujar SA. Dental movement acceleration: Literature review by an alternative scientific evidence method. World J Methodol. 2014 Sep 26;4(3):151-62. doi: 10.5662/wjm.v4.i3.151. eCollection 2014 Sep 26.
Results Reference
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The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients

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