Dental AnaesthesiaNCT06691269
Photobiomodulation and Tooth Analgesia
A study testing Photobiomodulation, Topical Benzocaine and Local Anesthesia in people with Dental Anaesthesia and Dental Pain, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anaesthesia, Dental Pain, Dental Analgesia
- What is being tested?
- Photobiomodulation, Topical Benzocaine and Local Anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children, aged 6-12 years, requiring routine dental treatment
Who cannot join
- Children with uncooperative behavior or signficant medical history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland School of Dentistry, Pediatric Clinics
Baltimore, Maryland, 21201
Vineet Dhar, BDS, MDS, PhD, 4107067970, VDhar@umaryland.edu
Kuei Ling Hsu, DDS, MS, Khsu@umaryland.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Photobiomodulation, Topical Benzocaine, Local Anesthesia
- Keywords
- photobiomodulation, dental analgesia, dental anesthesia
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called Low-level light therapy, near-infrared light
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 BenzocaineDrug
Topical Benzocaine at injection site to reduce discomfort of local infiltration
Local AnesthesiaDrug
Local infiltration using local anesthetics with epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Device: Photobiomodulation |
| no PBM- Study 2 | Active comparator | Topical benzocaine at injection site (prior to local anesthesia infiltration) Receives: 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. Receives: Device: Photobiomodulation |
| no PBM- Study 3 | Active comparator | Topical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration. Receives: Drug: Topical Benzocaine; Drug: Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-procedure (baseline), during, and immediately after procedure
Secondary outcomes (2)
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.
Measured: 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
Measured: baseline, immediately after response is felt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start7 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691269
- Sponsor's protocol ID
- HP-00112812
- Other IDs
- Project ID: 30063251
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39420491Shekarchi 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.
PubMed 35122442Kulkarni 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.
PubMed 35699807
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06691269
- Acronym / sponsor ID
- HP-00112812
- Conditions
- Dental Anaesthesia, Dental Pain, Dental Analgesia
- Keywords
- photobiomodulation, dental analgesia, dental anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PBM- Study 1 | Experimental | Device: PhotobiomodulationIn PBM group, the selected tooth will receive one burst of light application (20 seconds) before being subjected to sensibility testing and gingival probing. |
| 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 | Device: PhotobiomodulationPBM (one burst/ 20 seconds application) at injection site (prior to local anesthesia infiltration) |
| no PBM- Study 2 | Active comparator | Drug: Topical BenzocaineTopical benzocaine at injection site (prior to local anesthesia infiltration) |
| PBM- Study 3 | Experimental | Device: PhotobiomodulationPBM (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. |
| no PBM- Study 3 | Active comparator | Drug: Topical Benzocaine, Drug: Local AnesthesiaTopical benzocaine/Local infiltration followed by traditional tooth preparation with burs/handpiece and placement of restoration. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children, aged 6-12 years, requiring routine dental treatment
Key exclusion criteria (1 listed)
- Children with uncooperative behavior or signficant medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: Low-level light therapy, near-infrared lightPhotomodulation (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. | Device | PBM- Study 1, PBM- Study 2, PBM- Study 3 |
| Topical BenzocaineTopical Benzocaine at injection site to reduce discomfort of local infiltration | Drug | no PBM- Study 2, no PBM- Study 3 |
| Local AnesthesiaLocal infiltration using local anesthetics with epinephrine | Drug | no PBM- Study 3 |
Primary outcome
Study 1- Response to Cold Pulp (Pulp sensibility) testing
Time frame: during the intervention (application of cold stimuli)
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.
Study 1- Anxiety related to routine gingival probing
Time frame: pre-procedure (baseline) and immediately after the procedure
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
Study 1- Pain (physician documented) related to routine gingival probing
Time frame: pre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
Study 1- Self-reported Pain related to routine gingival probing
Time frame: pre-procedure (baseline) and immediately after 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
Study 2- Anxiety related to local anesthesia injection (local infiltration)
Time frame: pre-procedure (baseline) and immediately after the 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
Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration)
Time frame: pre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
Study 2- Self-reported Pain related to local anesthesia injection (local infiltration)
Time frame: pre-procedure (baseline) and immediately after 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
Study 2- Cooperative behavior related to local anesthesia injection (local infiltration)
Time frame: pre-procedure (baseline), during, and immediately after 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
Study 3- Anxiety during restorative procedure
Time frame: pre-procedure (baseline) and immediately after the 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
Study 3- Pain (physician documented) during restorative procedure
Time frame: pre-procedure (baseline), during procedure, and immediately after procedure
Name of the measurement: Heart rate Measurement tool: Pulse oximetry. Unit of measurement: Heart rate per minute
Study 3- Self-reported Pain during restorative procedure
Time frame: pre-procedure (baseline) and immediately after 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
Study 3- Cooperative behavior during restorative procedure
Time frame: pre-procedure (baseline), during, and immediately after 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
2 secondary outcomes
Study 1- Duration of tooth analgesia in PBM group
Time frame: baseline and immediately after response is felt
Study 1- Duration of soft tissue analgesia
Time frame: baseline, immediately after response is felt
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publication: PubMed 39420491Shrutha 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.
- Results publication: PubMed 35122442Shekarchi 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.
- Results publication: PubMed 35699807Kulkarni 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.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Anaesthesia
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
RecruitingObservational study
Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.
Dental Pain, Dental Anxiety
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Active, not recruiting
Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.
Dental Implants, Local Anesthesia
Active, not recruiting
Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars
Pain, Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation, Topical Benzocaine and Local Anesthesia in people with Dental Anaesthesia and Dental Pain, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vineet Dhar, BDS, MDS, PhD (410-706-7970, vdhar@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1- Response to Cold Pulp (Pulp sensibility) testing (time frame: during the intervention (application of cold stimuli)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06691269, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.