Clinical trial NCT06691269: Photobiomodulation and Tooth Analgesia
Official title: Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Anaesthesia
Dental Pain
Dental Analgesia
Keywords: photobiomodulation
dental analgesia
dental anesthesia
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Children with uncooperative behavior or signficant medical history

Primary outcomes:
measure: Study 1- Response to Cold Pulp (Pulp sensibility) testing
timeFrame: during the intervention (application of cold stimuli)
measure: Study 1- Anxiety related to routine gingival probing
timeFrame: pre-procedure (baseline) and immediately after the procedure
measure: Study 1- Pain (physician documented) related to routine gingival probing
timeFrame: pre-procedure (baseline), during procedure, and immediately after procedure
measure: Study 1- Self-reported Pain related to routine gingival probing
timeFrame: pre-procedure (baseline) and immediately after procedure
measure: Study 2- Anxiety related to local anesthesia injection (local infiltration)
timeFrame: pre-procedure (baseline) and immediately after the procedure
measure: Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration)
timeFrame: pre-procedure (baseline), during procedure, and immediately after procedure
measure: Study 2- Self-reported Pain related to local anesthesia injection (local infiltration)
timeFrame: pre-procedure (baseline) and immediately after procedure
measure: Study 2- Cooperative behavior related to local anesthesia injection (local infiltration)
timeFrame: pre-procedure (baseline), during, and immediately after procedure
measure: Study 3- Anxiety during restorative procedure
timeFrame: pre-procedure (baseline) and immediately after the procedure
measure: Study 3- Pain (physician documented) during restorative procedure
timeFrame: pre-procedure (baseline), during procedure, and immediately after procedure
measure: Study 3- Self-reported Pain during restorative procedure
timeFrame: pre-procedure (baseline) and immediately after procedure
measure: Study 3- Cooperative behavior during restorative procedure
timeFrame: pre-procedure (baseline), during, and immediately after procedure
Secondary outcomes:
measure: Study 1- Duration of tooth analgesia in PBM group
timeFrame: baseline and immediately after response is felt
measure: Study 1- Duration of soft tissue analgesia
timeFrame: baseline, immediately after response is felt
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.