BENITIONSClinical Trial Intelligence

Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain

2상 완료 NCT03848143

대상 질환Neuropathic Pain
임상 단계2상
스폰서Isabel Moreno Hay
상태완료
참여자 수8 명
중재(약물)onabotulinum toxin A
시작일2019년 9월 11일
완료일2025년 6월 30일
결과 공개일2026년 7월 30일

요약

Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differ

Change in Pain Intensity (Round 1)

Baseline, 3 month follow up · units on a scale

BOTOX3.91 ± .86 units on a scale

Change in Pain Intensity (Round 2)

Baseline, 6 month follow up · units on a scale

BOTOX3.33 ± 3.51 units on a scale

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