ClinicalTrials.gg
CompletedNCT05992233Updated Sep 26, 2024

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

An interventional study of Dual wavelength low level laser and Placebo in Molar, Third and Low-level Laser Therapy, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Oct 2021, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Molar, Third
  • Low-level Laser Therapy

Browse trials for

Keywords

  • photobiomodulation,
  • Impacted third molar
  • Pain
  • Edema
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 170 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

ASA I 18-40 years aged

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Plasebo

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

    Device: Placebo

Interventions

  • DeviceDual wavelength low level laser

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

  • DevicePlacebo

    Only red light applied.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperative-Postoperative (Day 2 and 7)

  2. 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.

    Time frame: Preoperative-Postoperative (Day 2 and 7)

  3. 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.

    Time frame: Preoperative-Postoperative (Day 2 and 7)

Secondary outcomes

  1. Operation Time

    The time from incision to the last suture was recorded.

    Time frame: During the surgery

  2. 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.

    Time frame: At 7th day.

07

Study locations

1 site
  • Gaziosmanpasa University
    Tokat Province, Turkey (Türkiye)
08

References and documents

Publications

  • Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62. PubMed 25653800 ↗
  • 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. PubMed 33058775 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05992233
Responsible party
esengul sen (Assistant Professor, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Aug 15, 2023
Start date
Oct 18, 2021
Primary completion
Oct 16, 2022
Completion
Dec 16, 2022
Last update
Sep 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion