Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases

NCT02568436 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2015
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a 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. Control group will undergo typical orthodontic treatment with the laser device applied the same manner but without being turned on (to get the placebo effect for pain reduction effect). This procedure will be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the end of the leveling and alignment stage.

Conditions

Maxillary Crowded Teeth

Outcome Measures

Primary Outcomes (2)

• Overall Leveling and Alignment Time (OLAT)

  As mentioned above

  This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.

• Change in Leveling and Alignment Improvement Percentage (LAIP)

  LAIP will be measured by dividing the amount of change in LII value at a specific time intervals (i.e. T3-T0, T2-T0, T1-T0; calculated by subtracting LII value at T1, T2 and T3 from LII value at (T0) by LII value at T0 (i.e. the beginning of treatment).

  this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII)

Secondary Outcomes (1)

• Change of levels of pain

  Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up.

Study Arms (2)

Conventional Decrowding

NO INTERVENTION

Crowded upper incisors will be treated in the conventional manner with a fake irradiation without using low level laser therapy.

Low Level Laser Therapy

EXPERIMENTAL

Each maxillary incisor will be subjected to low level laser therapy at specific times in order to accelerate tooth movement

Radiation: low level laser therapy

Interventions

low level laser therapy RADIATION

low level laser therapy is intended to accelerate tooth movement

Low Level Laser Therapy

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between (16 - 24) years.
• Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars.
• All upper teeth are existed (except for third molars).
• Patients have not undergone previous orthodontic treatment.
• Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
• Patient with good oral hygiene (Plaque Index less than 1).

You may not qualify if:

• Any medical condition affecting orthodontic tooth movement.
• Bad oral hygiene (Plaque Index greater than 1).
• Any peri-apical lesions developed during treatment.
• Patient lack of commitment toward follow-up appointments.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (7)

• 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

• Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.

  PMID: 22381489 BACKGROUND

• Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.

  PMID: 24984620 BACKGROUND

• Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.

  PMID: 24326198 BACKGROUND

• Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.

  PMID: 23153291 BACKGROUND

• Tortamano A, Lenzi DC, Haddad AC, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2009 Nov;136(5):662-7. doi: 10.1016/j.ajodo.2008.06.028.

  PMID: 19892282 BACKGROUND

• AlSayed Hasan MMA, Sultan K, Ajaj M, Voborna I, Hamadah O. Low-level laser therapy effectiveness in reducing initial orthodontic archwire placement pain in premolars extraction cases: a single-blind, placebo-controlled, randomized clinical trial. BMC Oral Health. 2020 Jul 20;20(1):209. doi: 10.1186/s12903-020-01191-7.

  PMID: 32690001 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohammad Moaffak Al-Sayed Hasan, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Kinda Sultan, DDS MSc PhD

  Senior Lecturer in Orthodontics, University of Damascus Dental School, SYRIA

  STUDY DIRECTOR

• Omar Hamadah, DDS MSc PhD

  Senior Lecturer, Oral Medicine Department, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2015
• First Posted: October 5, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

SY (1)