Photobiomodulation and Tooth Analgesia

NCT ID: NCT06691269

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Dental Anaesthesia; Dental Pain; Dental Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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.

no PBM - Study 1

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

PBM- Study 2

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

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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.

no PBM- Study 2

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

Group Type: ACTIVE_COMPARATOR

Topical Benzocaine

Intervention Type: DRUG

Topical Benzocaine at injection site to reduce discomfort of local infiltration

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.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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.

no PBM- Study 3

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

Group Type: ACTIVE_COMPARATOR

Topical Benzocaine

Intervention Type: DRUG

Topical Benzocaine at injection site to reduce discomfort of local infiltration

Local Anesthesia

Intervention Type: DRUG

Local infiltration using local anesthetics with epinephrine

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.

Intervention Type: DEVICE

Topical Benzocaine

Topical Benzocaine at injection site to reduce discomfort of local infiltration

Intervention Type: DRUG

Local Anesthesia

Local infiltration using local anesthetics with epinephrine

Intervention Type: DRUG

Other Intervention Names

Low-level light therapy, near-infrared light

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Children with uncooperative behavior or signficant medical history

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Maryland School of Dentistry, Pediatric Clinics

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vineet Dhar, BDS, MDS, PhD

Role: CONTACT

vdhar@umaryland.edu

410-706-7970

Kue-Ling Hsu, DDS, MS

Role: CONTACT

khsu@umaryland.edu

410-706-7970

Facility Contacts

Vineet Dhar, BDS, MDS, PhD

Role: primary

VDhar@umaryland.edu

4107067970

Kuei Ling Hsu, DDS, MS

Role: backup

Khsu@umaryland.edu

References

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.

Reference Type: RESULT

PMID: 39420491 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35122442 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35699807 (View on PubMed)

Other Identifiers

Project ID: 30063251

Identifier Type: OTHER

Identifier Source: secondary_id

HP-00112812

Identifier Type: -

Identifier Source: org_study_id