LED Therapy for Third Molar Surgery

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20-55
SponsorHuashan Hospital

About this trial

LED Therapy for third molar surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy Asians;

20-55 years old;

Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;

Disqualifiers

Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;

Women who are preparing for pregnancy, pregnant or breastfeeding;

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;

Bad habits, such as addicted to smoking, drinking, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • photobiomodulation

    Device

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

  • Antibiotic

    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 groups

50 Participants
are divided into 2 treatment groups
Group A: Control GroupSham comparator 1 intervention
Group B: Treatment GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain

Visual Analogue Scale,VAS

Time frame
Day 7
2

Swelling

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.

Time frame
Day 3; Day 7
3

Trismus

Trismus was evaluated by measuring the maximum mouth opening between the edges of the upper and lower central incisors with a calibrated ruler.

Time frame
Day 3; Day 7

Secondary outcomes

1

Quality of life score

OHIP-14 Scale

Time frame
Day 3; Day 7

Other outcomes

Sponsors and contacts

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