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NCT Number: NCT03646942

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

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 .

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Key information

Conditions

Malocclusion, Angle Class I Behavior Crowding Malocclusion Spatial Behavior Stomatognathic Diseases Tooth Diseases

Age range

17 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LLLT, soft tissue laser

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.

Primary outcomes

  1. Duration of tooth alignment

    Time frame: When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average

    Days required to complete tooth alignment will be counted.

  2. Change in Tooth Alignment at one month

    Time frame: T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment.

    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.

  3. Change in Tooth Alignment at two months

    Time frame: T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment.

    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.

  4. Change in Tooth Alignment at the end of Alignment Stage

    Time frame: 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

    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.

Secondary outcomes

  1. Change in the levels of pain and discomfort

    Time frame: 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

    Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment.

  2. Change in Patients' Acceptance

    Time frame: (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

    Assessment will be performed using a standardized questionnaire

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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