Photobiomodulation and Tooth Analgesia

NCT06691269 | Recruiting DMC

• 2 other identifiers: HP-00112812Project ID: 30063251
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

photobiomodulation; dental analgesia; dental anesthesia

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (2)

• Study 1- Duration of tooth analgesia in PBM group

  baseline and immediately after response is felt

• Study 1- Duration of soft tissue analgesia

  baseline, immediately after response is felt

Study Arms (6)

PBM- Study 1

EXPERIMENTAL

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

no PBM - Study 1

NO INTERVENTION

In the control (no PBM) group, the selected tooth will be subjected to sensibility testing and gingival probing without PBM.

PBM- Study 2

EXPERIMENTAL

PBM (one burst/ 20 seconds application) at injection site (prior to local anesthesia infiltration)

Device: Photobiomodulation

no PBM- Study 2

ACTIVE COMPARATOR

Topical benzocaine at injection site (prior to local anesthesia infiltration)

Drug: Topical Benzocaine

PBM- Study 3

EXPERIMENTAL

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

no PBM- Study 3

ACTIVE COMPARATOR

Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration.

Drug: Topical Benzocaine; Drug: Local Anesthesia

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.

Also known as: Low-level light therapy, near-infrared light

PBM- Study 1; PBM- Study 2; PBM- Study 3

Topical Benzocaine DRUG

Topical Benzocaine at injection site to reduce discomfort of local infiltration

no PBM- Study 2; no PBM- Study 3

Local Anesthesia DRUG

Local infiltration using local anesthetics with epinephrine

no PBM- Study 3

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with uncooperative behavior or signficant medical history

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Dentistry, Pediatric Clinics

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 39420491 RESULT

• 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.

  PMID: 35122442 RESULT

• 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.

  PMID: 35699807 RESULT

MeSH Terms

Conditions

Toothache

Interventions

Low-Level Light Therapy; Benzocaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Vineet Dhar, BDS, MDS, PhD

CONTACT

410-706-7970; vdhar@umaryland.edu

Kue-Ling Hsu, DDS, MS

CONTACT

410-706-7970; khsu@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design: This will be a series of three prospective, clinical studies in school-aged children requiring routine dental procedures. Study Population: Healthy children aged 6-12 years old requiring routine dental treatment at the study sites. Separate cohorts will be recruited for each trial after obtaining parental consent.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 15, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)