An interventional study of Piezosurgery and Low-level laser therapy in Class II Malocclusion, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 17 Years to 28 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
54 patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.
There are three groups:
The first group (control group): the canine retraction in this group will be performed in conventional method.
The second group (Experimental group): the canine retraction in this group will be performed in association with piezocision.
The third group (Experimental group): the canine retraction in this group will be performed in association with low-level laser therapy.
Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.
Regarding the Piezocision, three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
Regarding the low-level laser therapy (LLLT): GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction. After that, until the class I canine relationship will be achieved, the irradiation will be repeated every two weeks.
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at five evaluation times during the first month of canine retraction.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 58 is above the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
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Class II Division 1 malocclusion :
Good oral and periodontal health:
Exclusion Criteria:
Poor oral hygiene or Current periodontal disease:
Piezocision will be applied in this group of patients using a piezosurgery knife.
Procedure: Piezosurgery
Low-level laser therapy will be applied in this group of patients using a diode laser device.
Other: Low-level laser therapy
No acceleration method will be performed in this group.
Device: Traditional treatment
Three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\\point) will be applied around the upper canine in 10 sites from buccal and palatal.
The canine retraction in this group will be performed in conventional method. Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.
Change in the levels of pain
Assessment will be performed using questionnaires via Visual Analog scale.
Time frame: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Change in the levels of discomfort
Assessment will be performed using questionnaires via Visual Analog scale.
Time frame: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Change in the levels of swelling
Assessment will be performed using questionnaires via Visual Analog scale.
Time frame: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Levels of Eating difficulty
Assessment will be performed using questionnaires via Visual Analog scale.
Time frame: T1: after 24 hours of canine retraction commencement, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Change in the levels of satisfaction
Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.
Time frame: T5: 28 days following the commencement of the retraction.
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Damascus University