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

Malocclusion, Angle Class I Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646942
• Other study ID #: UDDS-Ortho-08-2018
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: July 2019
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Crowding
• Malocclusion
• Malocclusion, Angle Class I

Intervention

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.

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.

Locations

Country	Name	City	State
Syrian Arab Republic	Orthodontic Department, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (6)

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. — View Citation

Camacho AD, Velásquez 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. Review. — View 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. — View 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. English, German. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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	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
Secondary	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