"Effectiveness of Dual-Wavelength Laser Therapy in Third Molar Extraction Pain, Swelling, and Trismus"

Is Dual-wavelength Low-level Laser Therapy Effective in Reducing Pain, Swelling and Trismus After Impacted Mandibular Third Molar Extraction?

Objective: To investigate the effects of single session dual wavelength low dose laser therapy to be applied after third molar tooth extraction on postoperative pain, edema and physical activities.

Materials and Methods: Thirty-six patients who applied for the extraction of a Class III and position B lower impacted wisdom tooth were included in the study. The patients were divided into 2 groups as laser and control group. Envelope selection method was used for randomization of patients. After the surgery, a single session of double wavelength low-dose laser therapy was applied to the patients. On the 2nd and 7th postoperative days, pain was measured with the VAS scale, edema was measured by face measurements of 3 different points, and quality of life was measured with the modified Posse scale.

Study Overview

• Status: Completed
• Conditions: Molar, Third; Low-level Laser Therapy
• Intervention / Treatment: Device: Dual wavelength low level laser; Device: Placebo

Detailed Description

Objective and background: Pain, edema, and trismus are common problems after tooth extraction. Photobiomodulation therapy (PBMT) is frequently used as an adjunctive method to reduce these problems. However, there is no consensus in the literature regarding the type, power, session duration, and application frequency of the laser for this treatment method. The aim of this study is to examine the effectiveness of a single-session application of dual-wavelength PBMT (using a 904 nm GaAlAs infrared laser and a 650 nm red laser) on pain, edema, trismus, and the quality of life of patients following impacted mandibular third molar extraction.

Methods: The study included patients whose impacted mandibular third molars were to be extracted for prophylactic purposes. The patients were divided into two groups as the PBMT group and the placebo control group. Pain, swelling, maximum mouth opening, and quality of life parameters of the patients were evaluated.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey
    • Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

ASA I 18-40 years aged

Exclusion Criteria:

Pregnancy Lactating, Anticoagulant or antiaggregant medication Radiotherapy to the head and face area, Allergy to local anesthetics and prescribed drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual wavelength low dose laser; Immediately after suturing the patient, a low-dose laser application was performed on the laser group using the square probe (16 J/min) of the locally produced GRR laser device (Ankara, Turkey) for 5 minutes. The device combines a 22 mW GaAlAs infrared laser with a wavelength of 904 nm and a 10 mW red laser with a wavelength of 650 nm. The square probe contains 5 red lasers and 4 infrared lasers, covering an area of 30mm X 30mm.	Device: Dual wavelength low level laser; Application of double wavelength low level laser to the related area after tooth extraction.
Placebo Comparator: Plasebo; Laser probe will be applied to the control group patients, but the device was not operated.	Device: Placebo; Only red light applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling	It was determined according to facial swelling measurements. Tragus and soft tissue pogonion, tragus and lateral corner of the mouth were measured and recorded with a flexible ruler.	Preoperative-Postoperative (Day 2 and 7)
Maximum Mouth Opening	It is the procedure for determining the maximum mouth opening of the patient in mm. Measurements were determined as the distance between the incisal edges of the superior and inferior central teeth 11 and 41. In the absence of these teeth, other incisal teeth (21/31) in the adjacent half jaw were used. The maximum mouth opening determined before the operation was measured and recorded again on the 2nd and 7th days after the operation. The maximum mouth opening was measured with the help of a caliper.	Preoperative-Postoperative (Day 2 and 7)
Pain after surgery	Pain assessment of the patient was done with visual analog scale (VAS). According to this evaluation, the line of a certain length was divided into 10 equal parts. 0 = no pain on the line, 5 = moderate pain, 10 = unbearable pain. This statement will also be verbally reported to the patient and the patient was asked to mark the severity of his pain on this hide.	Preoperative-Postoperative (Day 2 and 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation Time	The time from incision to the last suture was recorded.	During the surgery
Quality of Life of the Patients'	A questionnaire form evaluates quality of life. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. It is a valid and reliable measure of the severity of symptoms after extraction of third molars, and of the impact of those symptoms on patients' perceived health.	At 7th day.

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Publications and helpful links

General Publications

• Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
• Domah F, Shah R, Nurmatov UB, Tagiyeva N. The Use of Low-Level Laser Therapy to Reduce Postoperative Morbidity After Third Molar Surgery: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2021 Feb;79(2):313.e1-313.e19. doi: 10.1016/j.joms.2020.09.018. Epub 2020 Sep 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): October 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Edema; photobiomodulation,; Impacted third molar
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm; Trismus
• Other Study ID Numbers: 21-KAEK-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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