Clinical trial NCT05992233: "Effectiveness of Dual-Wavelength Laser Therapy in Third Molar Extraction Pain, Swelling, and Trismus"
Official title: Is Dual-wavelength Low-level Laser Therapy Effective in Reducing Pain, Swelling and Trismus After Impacted Mandibular Third Molar Extraction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar, Third
Low-level Laser Therapy
Keywords: photobiomodulation,
Impacted third molar
Pain
Edema
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Swelling
timeFrame: Preoperative-Postoperative (Day 2 and 7)
measure: Maximum Mouth Opening
timeFrame: Preoperative-Postoperative (Day 2 and 7)
measure: Pain after surgery
timeFrame: Preoperative-Postoperative (Day 2 and 7)
Secondary outcomes:
measure: Operation Time
timeFrame: During the surgery
measure: Quality of Life of the Patients'
timeFrame: At 7th day.
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
References:
citation: Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
citation: 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.