LED Therapy for Third Molar Surgery (LTTMS)

LED Therapy Using 830 Nm in the Mandibular Third Molar Surgery: Double-blind Randomized Clinical Trial.

LED Therapy for third molar surgery

Study Overview

• Status: Not yet recruiting
• Conditions: Molar, Third; Photobiomodulation; Third Molar Surgery; Photobiomodulation Therapy
• Intervention / Treatment: Drug: Antibiotic; Device: photobiomodulation

Detailed Description

LED Therapy using 830 nm in the mandibular third molar surgery

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Yanjun Jane Dan, Medical Doctor; Phone Number: +86 15901940897; Email: 15901940897@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Yanjun Jane Dan, Medical Doctor; Phone Number: +86 15901940897; Email: 15901940897@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Drug: 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
Experimental: 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.	Drug: 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; Device: photobiomodulation; 830 nm LED was used to irradiate the post-extraction area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	OHIP-14 Scale	Day 3; Day 7

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 14, 2024
• Primary Completion (Estimated): February 14, 2025
• Study Completion (Estimated): April 14, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: photobiomodulation; third molar surgery; LED; 830 nm
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: KY2024-1088; Self-financed (Other Identifier: Self-financed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No