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

Not Applicable

Completed

• Conditions: Trismus; Facial Swelling; Pain
• Interventions: Device: GaAlAs laser

• Registration Number: NCT04280809
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary

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

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).

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Primary Completion: 2020-02-25
• Study Completion: 2020-03-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	GaAlAs laser	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.

Primary Outcome Measures

Name	Time	Method
Pain degree	at 48 hours after surgery	Likert scale
sIgA concentration	the second day after surgery	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)
Face swelling degree	on second day after surgery	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
Trismus degree	on day 2 postoperatively	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

Trial Locations

Locations (1)

Faculty of Odonto-Stomatology; 🇻🇳 Ho Chi Minh City, Dictrict 5, Vietnam