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Completed

NCT Number: NCT06526871

Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .

The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners

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Key information

Conditions

Tooth Movement Behavior Crowding Spatial Behavior

Age range

16 year–23 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AL-Azhar university

Cairo, Egypt

About this study

This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.

Intervention:

The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A well-behaved, compliant, and motivated patient.
  • Patients from 16 to 23 years old .
  • Patients with mild to moderate anterior lower crowding.
  • Full complement of teeth (except for wisdom teeth).
  • Class I Angle malocclusion .

Exclusion criteria

  • Patients with missed anterior teeth .
  • Class II or III Malocclusion (dental or skeletal ) .
  • Any systemic diseases that may interfere with assigned treatment plan .
  • Periodontal affection especially at lower anterior teeth .

Treatment and study plan

Low-Level Laser acceleration

Procedure

This intervention involves the application of Low-Level Laser Therapy (LLLT) using the Epic X device for patients undergoing orthodontic treatment. The protocol is designed to assess the effects of LLLT on pain reduction and treatment efficacy during the initial leveling and alignment phase of orthodontic therapy using clear aligners .

clear aligner therapy

Procedure

Clear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces.

Primary outcomes

  1. • Little irregularity index

    Time frame: through study completion, an average of 6 months

    The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.

Secondary outcomes

  1. • Treatment time

    Time frame: through study completion, an average of 6 months

    The duration of orthodontic treatment, including active treatment phases such as wearing aligners or undergoing procedures like interproximal reduction, is crucially monitored. This active treatment time is distinct from overall treatment duration, which encompasses intervals such as retention phases or breaks between aligner changes.

  2. • Number of aligners

    Time frame: through study completion, an average of 6 months

    The number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment.

  3. • Patient comfort and satisfaction

    Time frame: through study completion, an average of 6 months

    Patient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience.

  4. • Refinement rate

    Time frame: through study completion, an average of 6 months

    The refinement rate in orthodontics refers to the frequency and extent of adjustments made to aligners or appliances during treatment to achieve optimal tooth alignment. It is typically measured by assessing the need for additional aligners,

  5. • Digital cast accuracy

    Time frame: through study completion, an average of 6 months

    Digital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models.

  6. • Tooth movement accuracy

    Time frame: through study completion, an average of 6 months

    This process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time.

  7. • Software predictability

    Time frame: through study completion, an average of 6 months

    3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.

Sponsors and collaborators

Lead sponsor

Huda Abdelhakim

Other Gov

Registry information

Official study title

Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

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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