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

NCT03646942 | Completed DMC

• 1 other identifier: UDDS-Ortho-08-2018
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.treated with Low level laser therapy (LLLT)
2. 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.

Conditions

Malocclusion, Angle Class I; Crowding

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change in the levels of pain and discomfort

  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

  (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

Study Arms (2)

Lingual orthodontics

ACTIVE COMPARATOR

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; Device: Lingual Orthodontics

Low level laser therapy

EXPERIMENTAL

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

Radiation: low level laser therapy

Interventions

low level laser therapy RADIATION

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.

Also known as: LLLT, soft tissue laser

Lingual orthodontics; Low level laser therapy

Lingual Orthodontics DEVICE

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

Lingual orthodontics

Eligibility Criteria

• Age: 17 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related 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.

  PMID: 27869476 BACKGROUND

• 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.

  PMID: 23075062 BACKGROUND

• 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.

  PMID: 12132310 BACKGROUND

• 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.

  PMID: 25072362 BACKGROUND

• 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.

  PMID: 15334614 BACKGROUND

• 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.

  PMID: 25332914 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class I; Crowding

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, SYRIA

  STUDY CHAIR

• Wael Al-Rasheed Omer, DDS

  MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA

  PRINCIPAL INVESTIGATOR

• Wael Mahdi, DDS MSc PhD

  Associate Professor of Periodontics, University of Damascus Dental School, Damascus, SYRIA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: June 15, 2017
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)