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

Molar, Third Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992233
• Other study ID #: 21-KAEK-078
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: August 2023
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 16, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Volunteer ASA I individuals aged 18-40 years Exclusion Criteria: Those who are pregnant or lactating, Those receiving anticoagulant or antiaggregant medication, Those who have received radiotherapy to the head and face area, Those who are allergic to local anesthetics and prescribed drugs

Related Conditions & MeSH terms

• Low-level Laser Therapy
• Molar, Third
• Trismus

Intervention

Device:
• Dual wavelength low level laser
Application of double wavelength low level laser to the related area after tooth extraction.
• Placebo
Only red light applied.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Operation Time	The time from incision to the last suture was recorded.	During the surgery
Secondary	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.