LED Therapy for Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2025-04-14

Brief Summary

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LED Therapy for third molar surgery

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Detailed Description

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LED Therapy using 830 nm in the mandibular third molar surgery

Conditions

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Molar, Third Photobiomodulation Photobiomodulation Therapy Third Molar Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who underwent mandibular third molar extraction

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This study was a double-blind study in which the patient, the surgeon, and the statistician were all unaware of whether the patient received treatment or a placebo control light . Only the operator using the LED light was aware of this information. The assigned group was recorded on sealed and opaque envelopes. These cards were prepared by an independent person who was not involved in the study protocol. Once the patient underwent extraction and agreed to participate in this trial, this independent person opened the envelope to reveal the allocation.

Study Groups

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Control Group

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.

Group Type SHAM_COMPARATOR

Antibiotic

Intervention Type DRUG

ibuprofen 0.3 g bid for 3 days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 days after surgery

Treatment Group

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.

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type DEVICE

830 nm LED was used to irradiate the post-extraction area

Antibiotic

Intervention Type DRUG

ibuprofen 0.3 g bid for 3 days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 days after surgery

Interventions

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photobiomodulation

830 nm LED was used to irradiate the post-extraction area

Intervention Type DEVICE

Antibiotic

ibuprofen 0.3 g bid for 3 days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 days after surgery

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No