Photobiomodulation and Tooth Analgesia

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06691269
Status
Recruiting
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Conditions

  • Dental Anaesthesia
  • Dental Analgesia
  • Dental Pain

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Photobiomodulation — DEVICE
    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.
  • Topical Benzocaine — DRUG
    Topical Benzocaine at injection site to reduce discomfort of local infiltration
  • Local Anesthesia — DRUG
    Local infiltration using local anesthetics with epinephrine

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: PBM- Study 1
    In PBM group, the selected tooth will receive one burst of light application (20 seconds) before being subjected to sensibility testing and gingival probing.
  • No Intervention: no PBM - Study 1
    In the control (no PBM) group, the selected tooth will be subjected to sensibility testing and gingival probing without PBM.
  • Experimental: PBM- Study 2
    PBM (one burst/ 20 seconds application) at injection site (prior to local anesthesia infiltration)
  • Active Comparator: no PBM- Study 2
    Topical benzocaine at injection site (prior to local anesthesia infiltration)
  • Experimental: PBM- Study 3
    PBM (one burst/ 20 seconds application) followed by traditional tooth preparation with burs/handpiece and placement of restoration. Additional bursts may be provided every 20 minutes depending on the length of the procedure and patient-reported discomfort.
  • Active Comparator: no PBM- Study 3
    Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.

Primary Outcome Measure

Study 1- Response to Cold Pulp (Pulp sensibility) testing [ Time Frame: during the intervention (application of cold stimuli) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland School of Dentistry, Pediatric ClinicsBaltimoreMaryland21201
Vineet Dhar, BDS, MDS, PhD
[email protected]
4107067970
Kuei Ling Hsu, DDS, MS
[email protected]

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By research site
University of Maryland School of Dentistry, Pediatric Clinics· Baltimore, MD

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