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RecruitingNot ApplicableNCT06691269

Photobiomodulation and Tooth Analgesia

Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients

Sponsor

University of Maryland, Baltimore

Enrollment

200 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to test photobiomodulation (PBM) with a non-invasive light device for reducing discomfort during dental treatments in children. We plan to conduct a series of three clinical studies in 200 school-aged children requiring routine dental treatment. The first study aims to test if PBM works for tooth and soft tissue by assessing response to cold testing and probing of gums. The second study aims to test if use of PBM on soft tissues before injection reduces discomfort. The third study aims to test if PBM can be used to do simple dental fillings in baby teeth without numbing injection.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria1

  • Healthy children, aged 6-12 years, requiring routine dental treatment

Exclusion Criteria1

  • Children with uncooperative behavior or signficant medical history

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Interventions

DEVICEPhotobiomodulation

Photomodulation (PBM) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia/analgesia in dental patients. A patent pending near-infrared laser technology that aims to provide dental analgesia will be used for PBM. This intra-oral PBM device comes with a tip comprising of a series of photonic emitters with specific wavelengths that can go through the tooth structure and bone, blocking the nerve conduction like local anesthetics. Research has shown that one burst of light application (for about 20 second) can provide up to 15-20 minutes of pain relief. Based on existing research PBM does not present a serious risk to health, safety, or welfare of a subject.

DRUGTopical Benzocaine

Topical Benzocaine at injection site to reduce discomfort of local infiltration

DRUGLocal Anesthesia

Local infiltration using local anesthetics with epinephrine

Locations(1)

University of Maryland School of Dentistry, Pediatric Clinics

Baltimore, Maryland, United States

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NCT06691269