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

NCT05992233 | Completed

• 1 other identifier: 21-KAEK-078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar, Third; Low-level Laser Therapy

Keywords

photobiomodulation,; Impacted third molar; Pain; Edema

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Operation Time

  During the surgery

• Quality of Life of the Patients'

  At 7th day.

Study Arms (2)

Dual wavelength low dose laser

EXPERIMENTAL

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

Plasebo

PLACEBO COMPARATOR

Laser probe will be applied to the control group patients, but the device was not operated.

Device: Placebo

Interventions

Dual wavelength low level laser DEVICE

Application of double wavelength low level laser to the related area after tooth extraction.

Dual wavelength low dose laser

Placebo DEVICE

Only red light applied.

Plasebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I 18-40 years aged

You may not qualify if:

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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpasa University

Tokat Province, Turkey (Türkiye)

Location

Related Publications (2)

• Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.

  PMID: 25653800 BACKGROUND

• 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.

  PMID: 33058775 BACKGROUND

MeSH Terms

Conditions

Pain; Edema

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: hee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, for 7 days following surgery, postoperative swelling and maximum mouth opening values evaluated at 2nd and 7th days in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in quality of life using a questionnaire form.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: August 15, 2023
• Study Start: October 18, 2021
• Primary Completion: October 16, 2022
• Study Completion: December 16, 2022
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)