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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06526871
Enrollment
22
Registered
2024-07-30
Start date
2022-10-25
Completion date
2024-07-03
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Movement

Keywords

Aligner, Crowding, Laser

Brief summary

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

Detailed description

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.

Interventions

PROCEDURELow-Level Laser acceleration

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 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.

Sponsors

Huda Abdelhakim
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 23 Years
Healthy volunteers
No

Inclusion criteria

1. A well-behaved, compliant, and motivated patient. 2. Patients from 16 to 23 years old . 3. Patients with mild to moderate anterior lower crowding. 4. Full complement of teeth (except for wisdom teeth). 5. Class I Angle malocclusion .

Exclusion criteria

1. Patients with missed anterior teeth . 2. Class II or III Malocclusion (dental or skeletal ) . 3. Any systemic diseases that may interfere with assigned treatment plan . 4. Periodontal affection especially at lower anterior teeth .

Design outcomes

Primary

MeasureTime frameDescription
• Little irregularity indexthrough study completion, an average of 6 monthsThe 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

MeasureTime frameDescription
• Number of alignersthrough study completion, an average of 6 monthsThe number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment.
• Patient comfort and satisfactionthrough study completion, an average of 6 monthsPatient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience.
• Refinement ratethrough study completion, an average of 6 monthsThe 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,
• Treatment timethrough study completion, an average of 6 monthsThe 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.
• Tooth movement accuracythrough study completion, an average of 6 monthsThis process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time.
• Software predictabilitythrough study completion, an average of 6 months3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.
• Digital cast accuracythrough study completion, an average of 6 monthsDigital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026