Actively Recruiting
Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study
Led by University of Nove de Julho · Updated on 2024-07-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preventive use of Photobiomodulation to reduce swelling after the surgical removal of retained lower third molars, a common dental procedure. This study compares Photobiomodulation with the conventional use of a corticosteroid called Dexamethasone to see which better controls inflammation, pain, and related symptoms like lockjaw and difficulty swallowing following surgery. Healthy adults aged 18 to 50 who require this type of tooth extraction are included in this randomized controlled study. Participants are randomly assigned to one of two groups. The study group receives Photobiomodulation treatment using low-intensity lasers and LED devices applied inside and outside the mouth one hour before surgery, plus a placebo tablet that mimics Dexamethasone. The control group receives an 8 mg dose of Dexamethasone one hour before surgery plus a simulated Photobiomodulation treatment without active laser exposure. Both groups undergo the same surgical procedure for tooth extraction. Throughout the study, swelling, pain, lockjaw, local temperature (measured with a thermographic camera), difficulty swallowing, and the use of pain relievers are recorded before surgery and at 2 and 7 days after surgery. Mouth opening measurements and quality of life assessments are also taken at these times. Researchers will monitor all adverse effects and analyze the data to determine if Photobiomodulation offers benefits over corticosteroid treatment. Participation lasts for about one week post-surgery.
CONDITIONS
Brief Title
Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with retained lower third molars classified as classes II and III and/or B or C by Pell and Gregory Classification, in vertical or mesio-angular position.
- Indicated for extraction due to recurrent infections, poor anatomical position, or orthodontic reasons.
- Healthy individuals (ASA I) with no significant medical history.
- Male or female gender.
- Aged between 18 and 50 years.
- Good oral hygiene.
- Willing to participate and able to sign informed consent.
You will not qualify if you...
- Presence of local issues contraindicating surgery or complicating recovery, such as acute pericoronitis within the last 30 days or temporomandibular joint ankylosis.
- Smokers.
- Missing upper and lower central incisors.
- History of photosensitivity.
- Pregnant or breastfeeding.
- Current use of anti-inflammatory or analgesic medications.
- Allergic to any drugs used in the study, including amoxicillin, ketorolac, acetaminophen, dexamethasone, chlorhexidine, local anesthetics, or sodium bisulfite.
- Experiencing surgical complications like bleeding or difficulty during surgery.
- Surgery lasting longer than 90 minutes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 hour before surgery
Participants receive either photobiomodulation or corticosteroid/placebo treatment 1 hour before surgery to prevent postoperative complications.
1 visit (in-person, baseline)
Duration - Surgery day
Participants undergo extraction of retained lower third molars.
1 visit (in-person)
Duration - 7 days post-surgery
Participants are monitored for postoperative outcomes including edema, pain, lockjaw, local temperature, dysphagia, and analgesic use over one week.
3 visits (at baseline, 2 days, and 7 days post-surgery)
Trial Site Locations
Total: 1 location
1
Kristianne Porta Santos Fernandes
São Paulo, São Paulo, Brazil, 01525-000
Actively Recruiting
Research Team
K
Kristianne PS Fernandes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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