An interventional study of Low-Level Laser acceleration and clear aligner therapy in Tooth Movement, sponsored by Huda Abdelhakim. Completed at 1 site in Egypt. Open to female participants aged 16 Years to 23 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Huda Abdelhakim · Not applicable, Interventional, and Treatment
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
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.
This is the only study on the registry with Huda Abdelhakim as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ten patients treated with removable clear aligner
Procedure: clear aligner therapy
ten patients treated with removable clear aligner with application of Low-Level-Laser
Procedure: Low-Level Laser acceleration · Procedure: clear aligner therapy
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.
• Little irregularity index
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.
Time frame: through study completion, an average of 6 months
• Treatment time
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.
Time frame: through study completion, an average of 6 months
• Number of aligners
The number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment.
Time frame: through study completion, an average of 6 months
• Patient comfort and satisfaction
Patient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience.
Time frame: through study completion, an average of 6 months
• Refinement rate
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,
Time frame: through study completion, an average of 6 months
• Digital cast accuracy
Digital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models.
Time frame: through study completion, an average of 6 months
• Tooth movement accuracy
This process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time.
Time frame: through study completion, an average of 6 months
• Software predictability
3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.
Time frame: through study completion, an average of 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.