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

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City (Other)
Overall Status
Completed
CT.gov ID
NCT04280809
Collaborator
(none)
25
1
2
22.3
1.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: GaAlAs laser
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Postoperative Analgesic and Anti-inflammation Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Feb 25, 2020
Actual Study Completion Date :
Mar 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: GaAlAs laser
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

No Intervention: Non-laser

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

Outcome Measures

Primary Outcome Measures

  1. Pain degree [at 2 hours after stopping the feeling of numbness lips]

    Likert scale

  2. Pain degree [at 4 hours after stopping the feeling of numbness lips]

    Likert scale

  3. Pain degree [at 6 hours after stopping the feeling of numbness lips]

    Likert scale

  4. Pain degree [at 24 hours after surgery]

    Likert scale

  5. Pain degree [at 48 hours after surgery]

    Likert scale

  6. Face swelling degree [on first 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

  7. 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

  8. Trismus degree [on day 1 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

  9. 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

  10. 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)

Other Outcome Measures

  1. Face swelling degree [before 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

  2. sIgA concentration [before the 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Odonto-Stomatology Ho Chi Minh City Dictrict 5 Vietnam 70000

Sponsors and Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Study Director: Ly TB Nguyen, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Le Thanh Thai Ha, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT04280809
Other Study ID Numbers:
  • NT62 72 28 01
First Posted:
Feb 21, 2020
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2020