Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar

Study Overview
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Brief Summary
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Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM).

Detailed Description
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Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM), including pain level, postoperative facial swelling, trismus and non-stimulated saliva secretory immunoglobulin A (sIgA).

Official Title
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Postoperative Analgesic and Anti-inflammation Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar

Conditions
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Facial Swelling, Pain, Trismus

Intervention / Treatment
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* Device: GaAlAs laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: had two impacted lower third molars symmetrically in the same position as the classifications of Pell- Gregory and Winter diagnosed by 2D panoramic radiography Exclusion Criteria: Patients with systemic diseases such as cardiovascular disease, hypertension, diabetes mellitus, pregnant, local infections refused to participate in the study patients who did not follow-up visit would be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>Subsequently to the suture, laser was applied in the right or left side randomly on each patient, according to a sheet of randomization. GaAlAs laser (AMD Picasso, Dentsply Sirona, York, Pennsylvania, USA) with a wavelength of 810 nm was placed intraorally, at a distance of 1 cm in the position of the extracted tooth socket and circling in a 2 cm - diameter area. The power applied was 0.5 ± 20% W, continuously for 30 s. The total real energy released was 12.8 J and the real energy density applied was 4 J/cm2. | Device: GaAlAs laser<br>* GaAlAs laser (AMD Picasso, Dentsply Sirona, York, Pennsylvania, USA) with a wavelength of 810 nm was placed intraorally, at a distance of 1 cm in the position of the extracted tooth socket and circling in a 2 cm - diameter area. The power applied was 0.5 ± 20% W, continuously for 30 s. The total real energy released was 12.8 J and the real energy density applied was 4 J/cm2. Each patient was irradiated 3 times consecutively right after surgery, day 1 and day 2 after surgery<br>|
| No Intervention: Non-laser<br>Every patient, on the control side, the same handpiece was applied intraorally, but laser was not activated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain degree | Likert scale | at 2 hours after stopping the feeling of numbness lips | 
| Pain degree | Likert scale | at 4 hours after stopping the feeling of numbness lips | 
| Pain degree | Likert scale | at 6 hours after stopping the feeling of numbness lips | 
| Pain degree | Likert scale | at 24 hours after surgery | 
| Pain degree | Likert scale | at 48 hours after surgery | 
| Face swelling degree | Mark indelibly on the skin of points used to record the preoperative swelling level based on benchmarks A, B, C, D. A was the external canthus of the eye, B was the Gonion, C was the lip-commissure and D was the lowest point of the earlobe. The degree of face swelling was determined by using measuring tape (rounded to the nearest millimeter line): vertically from the external canthus of the eye to the Gonion (segment AB) and horizontally: from earlobe to the lip-commissure (CD segment). To evaluate generally face swelling, we computed the swelling area (mm2) approximately by the formula AB*CD/2 | on first day after surgery | 
| Face swelling degree | Mark indelibly on the skin of points used to record the preoperative swelling level based on benchmarks A, B, C, D. A was the external canthus of the eye, B was the Gonion, C was the lip-commissure and D was the lowest point of the earlobe. The degree of face swelling was determined by using measuring tape (rounded to the nearest millimeter line): vertically from the external canthus of the eye to the Gonion (segment AB) and horizontally: from earlobe to the lip-commissure (CD segment). To evaluate generally face swelling, we computed the swelling area (mm2) approximately by the formula AB*CD/2 | on second day after surgery | 
| Trismus degree | measuring the distance between the mesial angle of the central incisors of the upper and lower (maximum oral aperture, MOA) of the patient with a caliper | on day 1 postoperatively | 
| Trismus degree | measuring the distance between the mesial angle of the central incisors of the upper and lower (maximum oral aperture, MOA) of the patient with a caliper | on day 2 postoperatively | 
| sIgA concentration | Firstly, the saliva sample was centrifuged for 10 minutes, speed 3000 rpm, at 40 degrees Celsius. After eliminating oral mucosa cells, red blood cells, the 500 µl of the sample solution was added 5 µl proteolytic inhibitor to avoid cleavage of the sIgA antibodies in the sample to be investigated. The sample was vibrated with a vortex vibrator for 20 seconds and stored in -80°C. After collecting enough samples, the samples were performed the Elisa sandwich procedure according to the standard instructions of Kit Elisa Elabscience Human Secretory IgA (Elabscience Biotechnology, Houston, Texas, US) using Elisa IRE 96 SFRI Kit reader 450nm (SFRI, Saint-Jean-d'Illac, France) | the second day after surgery |