LED Therapy for Third Molar Surgery

NCT06640439 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: KY2024-1088Self-financed
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

LED Therapy for third molar surgery

Conditions

Molar, Third; Photobiomodulation; Photobiomodulation Therapy; Third Molar Surgery

Keywords

photobiomodulation; LED; 830 nm; third molar surgery

Outcome Measures

Primary Outcomes (3)

• Pain

  Visual Analogue Scale，VAS

  Day 7

• 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.

  Day 3; Day 7

• Trismus

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

  Day 3; Day 7

Secondary Outcomes (1)

• Quality of life score

  Day 3; Day 7

Study Arms (2)

Control Group

SHAM COMPARATOR

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.

Drug: Antibiotic

Treatment Group

EXPERIMENTAL

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.

Device: photobiomodulation; Drug: Antibiotic

Interventions

photobiomodulation DEVICE

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

Treatment Group

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

Control Group; Treatment Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.;
• Volunteers who have recently participated in other clinical trials;

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Interventions

Low-Level Light Therapy; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Yanjun Jane Dan, Medical Doctor

CONTACT

+86 15901940897; 15901940897@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Patients who underwent mandibular third molar extraction

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 14, 2024
• Primary Completion: February 14, 2025
• Study Completion: April 14, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)