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

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

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 .

Study Overview

• Status: Completed
• Conditions: Crowding; Malocclusion, Angle Class I
• Intervention / Treatment: Radiation: low level laser therapy; Device: Lingual Orthodontics

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 .

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Orthodontic Department, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of tooth alignment	Days required to complete tooth alignment will be counted.	When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
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.	T1: one day before the beginning of treatment; T2: at 30 days after the onset 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.	T1: one day before the beginning of treatment; T2: at 60 days after the onset 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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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
Change in Patients' Acceptance	Assessment will be performed using a standardized questionnaire	(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

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: 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 and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: UDDS-Ortho-08-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No