Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients
University of Maryland, Baltimore
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.
Description
Dental anxiety and fear of pain during procedures are major barriers to oral health care, especially among children. Traditional local anesthesia injections can be distressing for pediatric patients. The fear of needle and dental pain are perhaps among the top reasons for avoidance of dental care. Photomodulation (PBM) is a promising non-tissue penetrating (i.e. minimally invasive) approach for achieving tooth and soft tissue anesthesia/analgesia in dental patients.Investigators plan to use an intra-oral PBM device with a tip comprising of a series of photonic emitters with specific wavelength…
Eligibility
- Age range
- 6–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy children, aged 6-12 years, requiring routine dental treatment Exclusion Criteria: * Children with uncooperative behavior or signficant medical history
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
Location
- University of Maryland School of Dentistry, Pediatric ClinicsBaltimore, Maryland