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

NCT04280809 | Completed

• 1 other identifier: NT62 72 28 01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Facial Swelling; Pain; Trismus

Outcome Measures

Primary Outcomes (10)

• 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

Other Outcomes (2)

• Face swelling degree

  before surgery

• sIgA concentration

  before the surgery

Study Arms (2)

Laser

EXPERIMENTAL

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

Non-laser

NO INTERVENTION

Every patient, on the control side, the same handpiece was applied intraorally, but laser was not activated

Interventions

GaAlAs laser DEVICE

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

Laser

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• had two impacted lower third molars symmetrically in the same position as the classifications of Pell- Gregory and Winter diagnosed by 2D panoramic radiography

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Odonto-Stomatology

Ho Chi Minh City, Dictrict 5, 70000, Vietnam

Location

Related Publications (1)

• Le HT, Huynh NC, Nguyen-Ho QA, Nguyen TT, Le SH, Nguyen LT. Effect of Photobiomodulation Therapy on Reducing Acute Pain and Inflammation Following Surgical Removal of Impacted Mandibular Third Molars: A Randomized, Split-Mouth Clinical Trial. Photobiomodul Photomed Laser Surg. 2022 Apr;40(4):245-251. doi: 10.1089/photob.2021.0110. Epub 2022 Mar 29.

  PMID: 35353636 DERIVED

MeSH Terms

Conditions

Pain; Trismus

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Ly TB Nguyen, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Odonto-Stomatology

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 21, 2020
• Study Start: May 1, 2018
• Primary Completion: February 25, 2020
• Study Completion: March 10, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)