Photobiomodulation and Tooth Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation, Topical Benzocaine, Local Anesthesia.
- Who it may be relevant to
- Registry conditions: Dental Anaesthesia, Dental Pain, Dental Analgesia. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients
Overview
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.
Interventions
- 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. Re - Drug Topical Benzocaine
Topical Benzocaine at injection site to reduce discomfort of local infiltration - Drug Local Anesthesia
Local infiltration using local anesthetics with epinephrine
Primary outcome measures
- Study 1- Response to Cold Pulp (Pulp sensibility) testing [Time frame: during the intervention (application of cold stimuli)]
- Study 1- Anxiety related to routine gingival probing [Time frame: pre-procedure (baseline) and immediately after the procedure]
- Study 1- Pain (physician documented) related to routine gingival probing [Time frame: pre-procedure (baseline), during procedure, and immediately after procedure]
- Study 1- Self-reported Pain related to routine gingival probing [Time frame: pre-procedure (baseline) and immediately after procedure]
- Study 2- Anxiety related to local anesthesia injection (local infiltration) [Time frame: pre-procedure (baseline) and immediately after the procedure]
- Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration) [Time frame: pre-procedure (baseline), during procedure, and immediately after procedure]
- Study 2- Self-reported Pain related to local anesthesia injection (local infiltration) [Time frame: pre-procedure (baseline) and immediately after procedure]
- Study 2- Cooperative behavior related to local anesthesia injection (local infiltration) [Time frame: pre-procedure (baseline), during, and immediately after procedure]
- Study 3- Anxiety during restorative procedure [Time frame: pre-procedure (baseline) and immediately after the procedure]
- Study 3- Pain (physician documented) during restorative procedure [Time frame: pre-procedure (baseline), during procedure, and immediately after procedure]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Healthy children, aged 6-12 years, requiring routine dental treatment
Exclusion criteria
- Children with uncooperative behavior or signficant medical history
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Maryland School of Dentistry, Pediatric Clinics — Baltimore
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. PMID 39420491
- 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
- 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
Identifiers
NCT: NCT06691269 · HP-00112812 · Project ID: 30063251