Recruiting

Photobiomodulation

Sponsor:

University of Maryland, Baltimore

Code:

NCT06691269

Conditions

Dental Anaesthesia

Dental Pain

Dental Analgesia

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

Photobiomodulation

Topical Benzocaine

Local Anesthesia

Study Details

Brief 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

Study ID

NCT06691269

Start date

Jul 7, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with uncooperative behavior or signficant medical history

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

Topical Benzocaine

Topical Benzocaine at injection site to reduce discomfort of local infiltration

Local Anesthesia

Local infiltration using local anesthetics with epinephrine

Primary outcome measure

  • Study 1- Response to Cold Pulp (Pulp sensibility) testing [ Time Frame: during the intervention (application of cold stimuli) ]
  • Study 1- Anxiety related to routine gingival probing [ Time Frame: pre-procedure (baseline) and immediately after the procedure ]
  • Study 1- Pain (physician documented) related to routine gingival probing [ Time Frame: pre-procedure (baseline), during procedure, and immediately after procedure ]
  • Study 1- Self-reported Pain related to routine gingival probing [ Time Frame: pre-procedure (baseline) and immediately after procedure ]
  • Study 2- Anxiety related to local anesthesia injection (local infiltration) [ Time Frame: pre-procedure (baseline) and immediately after the procedure ]
  • Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration) [ Time Frame: pre-procedure (baseline), during procedure, and immediately after procedure ]
  • Study 2- Self-reported Pain related to local anesthesia injection (local infiltration) [ Time Frame: pre-procedure (baseline) and immediately after procedure ]
  • Study 2- Cooperative behavior related to local anesthesia injection (local infiltration) [ Time Frame: pre-procedure (baseline), during, and immediately after procedure ]
  • Study 3- Anxiety during restorative procedure [ Time Frame: pre-procedure (baseline) and immediately after the procedure ]
  • Study 3- Pain (physician documented) during restorative procedure [ Time Frame: pre-procedure (baseline), during procedure, and immediately after procedure ]
  • Study 3- Self-reported Pain during restorative procedure [ Time Frame: pre-procedure (baseline) and immediately after procedure ]
  • Study 3- Cooperative behavior during restorative procedure [ Time Frame: pre-procedure (baseline), during, and immediately after procedure ]

Central Contacts and Locations

Central contacts

Vineet Dhar, BDS, MDS, PhD

410-706-7970vdhar@umaryland.edu

Kue-Ling Hsu, DDS, MS

410-706-7970khsu@umaryland.edu

Locations

University of Maryland School of Dentistry, Pediatric Clinics

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Vineet Dhar, BDS, MDS, PhD

4107067970VDhar@umaryland.edu

Kuei Ling Hsu, DDS, MS

Khsu@umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • photobiomodulation
  • dental analgesia
  • dental anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-08-12.