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NCT Number: NCT06640439

LED Therapy for Third Molar Surgery

LED Therapy for third molar surgery

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location contact

Yanjun Jane Dan, Medical Doctor

CONTACT

[email protected]

+86 15901940897

About this study

LED Therapy using 830 nm in the mandibular third molar surgery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

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

Primary outcomes

  1. Pain

    Time frame: Day 7

    Visual Analogue Scale,VAS

  2. Swelling

    Time frame: 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.

  3. Trismus

    Time frame: 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 outcomes

  1. Quality of life score

    Time frame: Day 3; Day 7

    OHIP-14 Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Yanjun Jane Dan, Medical Doctor

CONTACT

[email protected]

+86 15901940897

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Acronym: LTTMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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