LED Therapy for Third Molar Surgery (LTTMS)

Fudan University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Photobiomodulation; Photobiomodulation Therapy; Third Molar Surgery; Molar, Third

Treatments: Device: photobiomodulation; Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06640439

Self-financed (Other Identifier)

KY2024-1088

Details and patient eligibility

About

LED Therapy for third molar surgery

Full description

LED Therapy using 830 nm in the mandibular third molar surgery

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy Asians;
2. 20-55 years old;
3. Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;

Exclusion criteria

1. Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
2. Women who are preparing for pregnancy, pregnant or breastfeeding;
3. Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
4. Bad habits, such as addicted to smoking, drinking, etc.;
5. Volunteers who have recently participated in other clinical trials;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Control Group

Sham Comparator group

Description:

The irradiation protocol was the same as that of the experimental group, and the light source used was simulated light. After surgery, patients took ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days.

Treatment:

Drug: Antibiotic

Treatment Group

Experimental group

Description:

LED light was irradiated 4 times (830 nm, 50 mW/cm2, 60 J/cm2, 1200 s) on D1 (before and after surgery), D2, and D3, which was extraoral irradiation. After surgery, ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days were taken.

Treatment:

Drug: Antibiotic

Device: photobiomodulation