RecruitingNot Applicable

Photobiomodulation and Tooth Analgesia

United States200 participantsStarted 2025-07-07

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy children, aged 6-12 years, requiring routine dental treatment Exclusion Criteria: * Children with uncooperative behavior or signficant medical history

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Study 1- Response to Cold Pulp (Pulp sensibility) testing

Timeframe: during the intervention (application of cold stimuli)

Study 1- Anxiety related to routine gingival probing

Timeframe: pre-procedure (baseline) and immediately after the procedure

Study 1- Pain (physician documented) related to routine gingival probing

Timeframe: pre-procedure (baseline), during procedure, and immediately after procedure

Study 1- Self-reported Pain related to routine gingival probing

Timeframe: pre-procedure (baseline) and immediately after procedure

Study 2- Anxiety related to local anesthesia injection (local infiltration)

Timeframe: pre-procedure (baseline) and immediately after the procedure

Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration)

Timeframe: pre-procedure (baseline), during procedure, and immediately after procedure

Trial details

NCT IDNCT06691269

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Vineet Dhar, BDS, MDS, PhD

410-706-7970 vdhar@umaryland.edu

View on ClinicalTrials.gov More Dental Anaesthesia trials