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Photobiomodulation and Tooth Analgesia

NCT06691269 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Dental Anaesthesia
  • Dental Pain
  • Dental Analgesia

Interventions

DEVICE

Photobiomodulation

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.

DRUG

Topical Benzocaine

Topical Benzocaine at injection site to reduce discomfort of local infiltration

DRUG

Local Anesthesia

Local infiltration using local anesthetics with epinephrine

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06691269 on ClinicalTrials.gov