LED Therapy for Third Molar Surgery

Early Phase 1

Not yet recruiting

• Conditions: Molar, Third; Photobiomodulation; Photobiomodulation Therapy; Third Molar Surgery
• Interventions: Drug: Antibiotic; Device: photobiomodulation

• Registration Number: NCT06640439
• Lead Sponsor: Huashan Hospital

Brief Summary

LED Therapy for third molar surgery

Detailed Description

LED Therapy using 830 nm in the mandibular third molar surgery

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study Start: 2024-10-14
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-02-14
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Antibiotic	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 Group	photobiomodulation	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 Group	Antibiotic	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.

Primary Outcome Measures

Name	Time	Method
Swelling	Day 3; Day 7	Facial swelling was measured in 2 planes: the distance between the tragus and lip commissure and the distance between the gonion and external canthus of the eye.
Pain	Day 7	Visual Analogue Scale，VAS
Trismus	Day 3; Day 7	Trismus was evaluated by measuring the maximum mouth opening between the edges of the upper and lower central incisors with a calibrated ruler.

Secondary Outcome Measures

Name	Time	Method
Quality of life score	Day 3; Day 7	OHIP-14 Scale

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China