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Completed

NCT Number: NCT02568436

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

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.

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Key information

Conditions

Maxillary Crowded Teeth

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment.

Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption.

A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Low level laser therapy

Radiation

low level laser therapy is intended to accelerate tooth movement

Primary outcomes

  1. Overall Leveling and Alignment Time (OLAT)

    Time frame: 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.

    As mentioned above

  2. Change in Leveling and Alignment Improvement Percentage (LAIP)

    Time frame: 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)

    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).

Secondary outcomes

  1. Change of levels of pain

    Time frame: 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.

    Using a visual analog scale, each patient will indicate the severity of his/her perceived pain.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of Low-Level Laser Therapy (LLLT) Effectiveness in Accelerating Orthodontic Tooth Movement For Dental Crowding Cases: A Randomized Controlled Clinial Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
Registry last updated
Jul 11, 2016

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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