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

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT05992233
Collaborator
(none)
40
1
2
13.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dual wavelength low level laser
  • Device: Placebo
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Is Dual-wavelength Low-level Laser Therapy Effective in Reducing Pain, Swelling and Trismus After Impacted Mandibular Third Molar Extraction?
Actual Study Start Date :
Oct 18, 2021
Actual Primary Completion Date :
Oct 16, 2022
Actual Study Completion Date :
Dec 16, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Swelling [Preoperative-Postoperative (Day 2 and 7)]

    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.

  2. Maximum Mouth Opening [Preoperative-Postoperative (Day 2 and 7)]

    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.

  3. Pain after surgery [Preoperative-Postoperative (Day 2 and 7)]

    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.

Secondary Outcome Measures

  1. Operation Time [During the surgery]

    The time from incision to the last suture was recorded.

  2. Quality of Life of the Patients' [At 7th day.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gaziosmanpasa University Tokat Turkey

Sponsors and Collaborators

  • Tokat Gaziosmanpasa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esengul Sen, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier:
NCT05992233
Other Study ID Numbers:
  • 21-KAEK-078
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
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
Keywords provided by Esengul Sen, Assistant Professor, Tokat Gaziosmanpasa University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2023