Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity Induced by Tooth Bleaching
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have at least 28 teeth in the cavity
- •Good oral and general health
排除标准
- •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.
研究组 & 干预措施
Placebo group
The placebo gel (PG) (natrosol 4%) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany)) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
干预措施: Natrosol 4% Gel (Drug)
Control group
gel with 5% potassium nitrate and 2% sodium fluoride The gel with 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with a microbrush actively, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of follow-up. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two
干预措施: Potassium nitrate and sodium fluoride (Drug)
Experimental group
The experimental 2% cannabidiol gel (GCBD) will be applied to the buccal surfaces of the central and lateral incisors, canines and upper and lower premolars, with an active microbrush, for 10 minutes. Subsequently, all groups will undergo in-office whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be carried out using a form consisting of a visual analogue scale (VAS), patients will be instructed to record tooth sensitivity daily, during the 21 days of followup. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).
干预措施: Cannabidiol (CBD) Gel (Drug)
结局指标
主要结局
Measure Degree of Tooth Sensitivity (pain) by a visual analog scale (VAS) After Tooth Whitening
时间窗: immediately after the intervention, and for a period of 21 days of treatment
Experimental cannabidiol and gel (experimental group) and potassium nitrate gel (control group) can change sensitivity related to tooth whitening with hydrogen peroxide 35%. So it is necessary measure this pain. The volunteers will mark on the scale (VAS) the level (1-10) of sensitivity immediately after the intervention, and for a period of 21 days of treatment.
次要结局
- Change in Color of Teeth Bleached by spectrophotometer (VITA Easyshade)(quantitative method: (ΔE00)(There will be two colors readings: - 1: Ti: Base line (Until star first bleaching session); - 2: Tf: one week after the last bleaching session.)
研究者
Jesuína Lamartine Nogueira Araújo
Principal Investigator: Clinical Professor
Universidade Federal do Para