Evaluation the effect of photobiomodulation therapy with 810 nm Diode laser on the recovery of mid face sensation following maxillary Lefort 1 surgery: A triple-blind, split-face, randomized controlled trial

determine the effect of photobiomodulation therapy with ۸۱۰ nm Diode laser on the recovery of mid face sensation following maxillary Lefort ۱ surgery

The clinical trial will be performed as a split face, three-way blind, randomized, phase 3, on 10 patients. Excel random function was used for randomization.

This blind 3-sided clinical trial (patient, examiner and statistical analyst) is performed as a split face on patients aged 18 to 40 years who have referred to Shariati and Sina hospitals of Tehran University of Medical Sciences for Lefort 1 osteotomy. On the intervention side, laser therapy will be performed on days 1, 3, 7, 14, 21 and 28 after the operation. The laser probe on the control side is inactive at similar points and the patient will not know if the laser probe is on or off. All patients will be evaluated for neuroscience with standard sensory tests before and after surgery, as well as on days 1, 3, 7, 14, 21, 28, and 35 in the middle of the face on both sides of the control and intervention.

Inclusion criteria: No previous maxillofacial trauma , Absence of oral diseases, No uncontrolled systemic diseases Exclusion criteria: Existence or history of trauma or head and neck malignancies, Pregnancy and lactation, experiencing fractures or obvious nerve damage during surgery, Postoperative infection, Contraindication laser therapy

In the middle part of the participants' face, one side is considered as the intervention area and the other side is considered as the control. Intervention: Laser therapy on days 1, 3, 7, 14, 21 and 28 after surgery Control: Lack of laser therapy

2point discrimination test thermal discrimination test sharp blunt discrimination test brush stroke directional test Patient satisfaction level using visual analogue scale

In this study, using a simple randomization method with a table of random numbers, the intervention is assigned to one of the two right or left. In this way, in the table of random numbers from top to bottom, in case of collision with odd number, the intervention will be assigned to the right, and in case of collision with even number, the intervention will be assigned to the left. Move in the columns of the random number table from top to bottom until the number of samples is exhausted.

During laser treatment, the patient will not feel any heat changes or pain during the laser treatment. The device probe is used on the control side with the same time as intended on the intervention side in off mode. The patient (according to the above points) will be blind to which side of the mouth he receives the laser from. The person who measures the results of the study will be blind to this allocation. Also, labels A and B are considered for both intervention and control so that the statistical analyst is blind to the end of the data analysis relative to the allocation.

Data file and statistical analysis will be shared.

3 months after data collection

The above information will be made available to the public in the form of appendices along with the published article.

To better understand the study findings as well as a reference for future studies

From the website of the journal in which the article will be published

The data file and statistical analysis will be available to everyone.

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