Photobiomodulation and Tooth Analgesia

Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Pain; Dental Anaesthesia; Dental Analgesia
• Intervention / Treatment: Device: Photobiomodulation; Drug: Topical Benzocaine; Drug: Local Anesthesia

Detailed 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 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. This could significantly reduce dental anxiety and facilitate access to care and the implications of such an alternative to needles will be a gamechanger especially in pediatric dentistry. The proposed randomzied clinical trials will evaluate if photobiomodulation (PBM) with the near-infrared device produces dental analgesia comparable to local anesthetic injection in pediatric patients. This will be a series of three prospective, clinical studies in 200 school-aged children aged 6-12 years requiring routine dental procedures. The first trial will test the effectiveness of PBM in tooth and soft tissue analgesia by assessing response to diagnostic approaches such as cold pulp testing and gingival probing. The second trial will assess the pre-emptive analgesic effect of PBM on soft tissues at the site of injection prior to local anesthesia infiltration to reduce the discomfort of injection, and the third trial will assess effectiveness of PBM in providing tooth analgesia (compared to routinely used topical anesthesia/local infiltration) for simple restorative procedures in primary teeth.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vineet Dhar, BDS, MDS, PhD; Phone Number: 410-706-7970; Email: vdhar@umaryland.edu
• Study Contact Backup: Name: Kue-Ling Hsu, DDS, MS; Phone Number: 410-706-7970; Email: khsu@umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Dentistry, Pediatric Clinics
      • Contact: Vineet Dhar, BDS, MDS, PhD; Phone Number: 4107067970; Email: VDhar@umaryland.edu
      • Contact: Kuei Ling Hsu, DDS, MS; Email: Khsu@umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children with uncooperative behavior or signficant medical history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Low-level light therapy, near-infrared light
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)	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.; Other Names: Low-level light therapy, near-infrared light
Active Comparator: no PBM- Study 2; Topical benzocaine at injection site (prior to local anesthesia infiltration)	Drug: Topical Benzocaine; Topical Benzocaine at injection site to reduce discomfort of local 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.	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.; Other Names: Low-level light therapy, near-infrared light
Active Comparator: no PBM- Study 3; Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.	Drug: Topical Benzocaine; Topical Benzocaine at injection site to reduce discomfort of local infiltration; Drug: Local Anesthesia; Local infiltration using local anesthetics with epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1- Response to Cold Pulp (Pulp sensibility) testing	Name of measurement: Response to cold pulp testing. Measurement tool: Child's acknowledgement of cold sensation. A small amount of cold spray (Endo Ice/Ethyl Chloride) will be sprayed onto a cotton pellet, and gently place the cotton pellet on the middle third of the buccal surface of the tooth for a few seconds or until the child indicates a sensation. Child will be asked to raise their hand when they feel a cold sensation. Unit of measurement: Response will be noted (Yes/No), if the cold sensation is felt by the child on application of cold stimulus. Difference in cold pulp testing between PBM and no PBM group.	during the intervention (application of cold stimuli)
Study 1- Anxiety related to routine gingival probing	Name of the measurement: Assessment of anxiety Measurement tool: Visual analogue scale (VAS)- a 100-mm horizontal line with two extremes "not anxious" (left) to "very anxious" (right). Measurement unit: rating scale	pre-procedure (baseline) and immediately after the procedure
Study 1- Pain (physician documented) related to routine gingival probing	Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute	pre-procedure (baseline), during procedure, and immediately after procedure
Study 1- Self-reported Pain related to routine gingival probing	Name of the measurement: Pain/discomfort Measurement tool: Self-reported Wong Baker faces Scale (six-point scale from score 0 (no hurt) to score 10 (hurts worst). Unit of measurement: Rating Scale	pre-procedure (baseline) and immediately after procedure
Study 2- Anxiety related to local anesthesia injection (local infiltration)	Name of the measurement: Assessment of procedural anxiety Measurement tool: Visual analogue scale (VAS)- a 100-mm horizontal line with two extremes "not anxious" (left) to "very anxious" (right). Measurement unit: rating scale	pre-procedure (baseline) and immediately after the procedure
Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration)	Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute	pre-procedure (baseline), during procedure, and immediately after procedure
Study 2- Self-reported Pain related to local anesthesia injection (local infiltration)	Name of the measurement: Pain/discomfort Measurement tool: Self-reported Wong Baker faces Scale (six-point scale from score 0 (no hurt) to score 10 (hurts worst). Unit of measurement: Rating Scale	pre-procedure (baseline) and immediately after procedure
Study 2- Cooperative behavior related to local anesthesia injection (local infiltration)	Name of the measurement: Cooperative behavior Measurement tool: Frankel's Behavior rating scale (definitely negative, negative, positive, definitely positive) Unit of measurement: Rating Scale	pre-procedure (baseline), during, and immediately after procedure
Study 3- Anxiety during restorative procedure	Name of the measurement: Assessment of procedural anxiety Measurement tool: Visual analogue scale (VAS)- a 100-mm horizontal line with two extremes "not anxious" (left) to "very anxious" (right). Measurement unit: rating scale	pre-procedure (baseline) and immediately after the procedure
Study 3- Pain (physician documented) during restorative procedure	Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute	pre-procedure (baseline), during procedure, and immediately after procedure
Study 3- Self-reported Pain during restorative procedure	Name of the measurement: Pain/discomfort Measurement tool: Self-reported Wong Baker faces Scale (six-point scale from score 0 (no hurt) to score 10 (hurts worst). Unit of measurement: Rating Scale	pre-procedure (baseline) and immediately after procedure
Study 3- Cooperative behavior during restorative procedure	Name of the measurement: Cooperative behavior Measurement tool: Frankel's Behavior rating scale (definitely negative, negative, positive, definitely positive) Unit of measurement: Rating Scale	pre-procedure (baseline), during, and immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1- Duration of tooth analgesia in PBM group	Name of measurement: Duration or time taken for response to cold pulp testing. Measurement tool: Child's acknowledgement of cold sensation. A small amount of cold spray (Endo Ice/Ethyl Chloride) will be sprayed onto a cotton pellet, and gently place the cotton pellet on the middle third of the buccal surface of the tooth for a few seconds or until the child indicates a sensation. Child will be asked to raise their hand when they feel a cold sensation. Unit of measurement: Time (measured in seconds) taken for response in PBM group and no PBM groups.	baseline and immediately after response is felt
Study 1- Duration of soft tissue analgesia	Name of measurement: Duration of analgesia or time taken for patient to respond to gingival probing Measurement tool: Yes/No to discomfort experienced during gingival probing Unit of measurement: Time in seconds	baseline, immediately after response is felt

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Publications and helpful links

General Publications

• Shrutha SP, Havale R, Aishwarya BG, Raj S, Quazi N, Prasad V, Guttiganur N, Kandalam R. Use of Three Pre-Injection Procedures to Reduce Pain Perception of Intraoral Injections in Eight- to 12-Year-Old Children: Randomized Controlled Trial. Pediatr Dent. 2024 Sep 15;46(5):306-311.
• Shekarchi F, Nokhbatolfoghahaei H, Chiniforush N, Mohaghegh S, Haeri Boroojeni HS, Amini S, Biria M. Evaluating the Preemptive Analgesic Effect of Photo-biomodulation Therapy on Pain Perception During Local Anesthesia Injection in Children: A Split-mouth Triple-blind Randomized Controlled Clinical Trial. Photochem Photobiol. 2022 Sep;98(5):1195-1200. doi: 10.1111/php.13605. Epub 2022 Feb 17.
• Kulkarni S, George R, Love R, Ranjitkar S. Effectiveness of photobiomodulation in reducing pain and producing dental analgesia: a systematic review. Lasers Med Sci. 2022 Sep;37(7):3011-3019. doi: 10.1007/s10103-022-03590-4. Epub 2022 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: photobiomodulation; dental anesthesia; dental analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Tooth Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Facial Pain; Agnosia; Toothache; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Benzocaine
• Other Study ID Numbers: HP-00112812; Project ID: 30063251 (Other Identifier: University of Maryland, Baltimore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No