Photobiomodulation and Tooth Analgesia

Официальное название

Evaluation of a Photobiomodulation Device for Dental Analgesia in Pediatric Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Препарат Topical Benzocaine
  Topical Benzocaine at injection site to reduce discomfort of local infiltration
• Препарат Local Anesthesia
  Local infiltration using local anesthetics with epinephrine

Первичные конечные точки

• Study 1- Response to Cold Pulp (Pulp sensibility) testing [Срок оценки: during the intervention (application of cold stimuli)]
• Study 1- Anxiety related to routine gingival probing [Срок оценки: pre-procedure (baseline) and immediately after the procedure]
• Study 1- Pain (physician documented) related to routine gingival probing [Срок оценки: pre-procedure (baseline), during procedure, and immediately after procedure]
• Study 1- Self-reported Pain related to routine gingival probing [Срок оценки: pre-procedure (baseline) and immediately after procedure]
• Study 2- Anxiety related to local anesthesia injection (local infiltration) [Срок оценки: pre-procedure (baseline) and immediately after the procedure]
• Study 2- Pain (physician documented) related to local anesthesia injection (local infiltration) [Срок оценки: pre-procedure (baseline), during procedure, and immediately after procedure]
• Study 2- Self-reported Pain related to local anesthesia injection (local infiltration) [Срок оценки: pre-procedure (baseline) and immediately after procedure]
• Study 2- Cooperative behavior related to local anesthesia injection (local infiltration) [Срок оценки: pre-procedure (baseline), during, and immediately after procedure]
• Study 3- Anxiety during restorative procedure [Срок оценки: pre-procedure (baseline) and immediately after the procedure]
• Study 3- Pain (physician documented) during restorative procedure [Срок оценки: pre-procedure (baseline), during procedure, and immediately after procedure]

Вторичные конечные точки (2)

• Study 1- Duration of tooth analgesia in PBM group [Срок оценки: baseline and immediately after response is felt]
• Study 1- Duration of soft tissue analgesia [Срок оценки: baseline, immediately after response is felt]

Критерии участия

Критерии включения

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

Критерии исключения

• Children with uncooperative behavior or signficant medical history

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Maryland School of Dentistry, Pediatric Clinics — Baltimore

Публикации

• 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

Идентификаторы

NCT: NCT06691269 · HP-00112812 · Project ID: 30063251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗