Clinical trial NCT06526871: Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .
Official title: Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Movement
Keywords: Aligner
Crowding
Laser
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-07-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: • Little irregularity index
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: • Treatment time
timeFrame: through study completion, an average of 6 months
measure: • Number of aligners
timeFrame: through study completion, an average of 6 months
measure: • Patient comfort and satisfaction
timeFrame: through study completion, an average of 6 months
measure: • Refinement rate
timeFrame: through study completion, an average of 6 months
measure: • Digital cast accuracy
timeFrame: through study completion, an average of 6 months
measure: • Tooth movement accuracy
timeFrame: through study completion, an average of 6 months
measure: • Software predictability
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AL-Azhar university
Study officials:
affiliation: Al-Azhar University
name: Samir A Ibrahim, professor
role: PRINCIPAL_INVESTIGATOR
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