Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity

Официальное название

Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching

Обзор

The goal of this clinical trial will be to evaluate the effect applying an experimental gel based on cannabidiol oil (CBD) on tooth sensitivity induced by tooth bleaching with 35% hydrogen peroxide (HP). Volunteers will be selected and allocated to the following groups: GP - placebo gel, GCBD - experimental cannabidiol gel and GKF - Potassium Nitrate and Sodium Fluoride Gel. In each group, the corresponding desensitizing gel will be applied to on the teeth for 10 minutes. All groups will then undergo in-office whitening treatment with 35% hydrogen peroxide. Patients will be instructed to record tooth sensitivity on a daily basis during the 21 days of follow-up. Pain intensity will be measured using a visual analog scale (VAS), while the risk of developing sensitivity will be recorded after each session of the whitening procedure, with two response option.

Вмешательства

• Препарат Potassium nitrate and sodium fluoride
  Gel with 5% potassium nitrate and 2% sodium fluoride gel of 5% potassium nitrate and 2% sodium fluoride for topical application to teeth before bleaching with hydrogen peroxide
• Препарат Cannabidiol (CBD) Gel
  Cannabidiol gel for teeth ( 2% cannabidiol oil) before bleaching with hydrogen peroxide
• Препарат Natrosol 4% Gel
  placebo gel (natrosol-based gel 4%) for topical application to teeth before bleaching with hydrogen peroxide.

Первичные конечные точки

• Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening [Срок оценки: immediately after the intervention, and for a period of 21 days of treatment]

Вторичные конечные точки (1)

• Change in Color of Teeth Bleached by spectrophotometer (VITA Easyshade)(quantitative method: (ΔE00) [Срок оценки: There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.]

Критерии участия

Критерии включения

• Participants must have at least 28 teeth in the cavity
• Good oral and general health

Критерии исключения

• active caries or periodontal disease
• visible cracks in front teeth upper or lower
• with evident malocclusion
• restorations and prosthetics in teeth anterior teeth
• gastroesophageal disorders
• severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
• dentin exposure in anterior teeth and /or later
• parafunctional habits
• tooth sensitivity
• whitening treatment prior to or undergoing orthodontic treatment
• Furthermore, smokers, pregnant or breastfeeding women do not will be included.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Federal University of Pará School of Dentistry — Belém

Публикации

• Sano IS, de Almeida AS, Xavier GMB, Paes YFO, Silva CM, de Freitas MCC, da Costa RS, Araujo JLN. Synthesis of an experimental gel containing cannabidiol oil and evaluation of effects on bleached bovine enamel. Odontology. 2026 Jan;114(1):108-120. doi: 10.1007/s10266-025-01105-5. Epub 2025 Apr 19. PMID 40253312

Идентификаторы

NCT: NCT07027566 · PPGOUFPAFO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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