Clinical trial NCT03646942: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class I
Crowding
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 36
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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 .

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

Primary outcomes:
measure: Duration of tooth alignment
timeFrame: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average
measure: Change in Tooth Alignment at one month
timeFrame: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.
measure: Change in Tooth Alignment at two months
timeFrame: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.
measure: Change in Tooth Alignment at the end of Alignment Stage
timeFrame: 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 outcomes:
measure: Change in the levels of pain and discomfort
timeFrame: 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
measure: Change in Patients' Acceptance
timeFrame: (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
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Orthodontic Department, University of Damascus Dental School
Study officials:
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, SYRIA
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
affiliation: MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA
name: Wael Al-Rasheed Omer, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Periodontics, University of Damascus Dental School, Damascus, SYRIA
name: Wael Mahdi, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.