Application of Acmella Oleracea (Jambu) Bioadhesive Film in Reducing Tooth Sensitivity Induced by Dental Bleaching: a Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
研究概览
简要总结
Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.
详细描述
Dental bleaching with hydrogen peroxide (HP) is a frequent treatment in dentistry, but it can present some adverse effects such as alterations in the surface structure of the teeth and tooth sensitivity. This study aimed to evaluate an experimental bioadhesive film of Acmella oleracea (jambu) extract on tooth sensitivity caused by bleaching with 35% hydrogen peroxide and its impact on the participants' oral health-related quality of life (OHRQoL). Seventy-two volunteers were divided into three different groups: GCP - Control group with bioadhesive bioplastic film without spilanthol, GKF - Desensitizing treatment group with 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and GAO - Group with the experimental bioadhesive film of Acmella oleracea extract. In each group, the corresponding product was applied to the vestibular surfaces of the visible teeth for 10 minutes. Subsequently, all groups underwent an in-office dental bleaching protocol with 35% hydrogen peroxide. Tooth sensitivity was measured using the visual analog scale (VAS), the impact on oral health-related quality of life (OHRQoL) was assessed using the QEDH-15 questionnaire at baseline and at the last sensitivity record, and color measurement was performed at two time points: at baseline and one week after the 3rd bleaching session. Data were subjected to the Shapiro-Wilk normality test. For normally distributed variables, we used repeated measures ANOVA for intragroup analysis and one-way ANOVA for intergroup comparisons, with post-hoc tests when applicable. For non-parametric data, Friedman (intragroup) and Kruskal-Wallis (intergroup) tests were used. Color analysis (ΔE), considering the difference between initial and final times, and the impact on oral health-related quality of life followed the same statistical criteria, according to the data distribution. The significance level adopted was 5% for all analyses. The bioadhesive film is expected to have an effect on nociception and reduce sensitivity caused by bleaching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
Bioadhesive film of Acmella Oleracea (jambu)
The bioadhesive film of Acmella Oleracea (jambu) will be applied to the vestibular surfaces of the upper and lower central and lateral incisors, canines, and premolars, like a tape, for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity assessment will be performed using a form composed of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
干预措施: Bioadhesive film of Acmella Oleracea (jambu) (Drug)
Gel containing 5% potassium nitrate and 2% sodium fluoride
A gel containing 5% potassium nitrate and 2% sodium fluoride (NKFG) will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars using an active microbrush for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a visual analog scale (VAS) form. Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. For color measurement, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
干预措施: Gel containing 5% potassium nitrate and 2% sodium fluoride. (Drug)
Spilanthol-free bioadhesive bioplastic film
A spilanthol-free bioadhesive film made of bioplastic will be applied to the buccal surfaces of the upper and lower central and lateral incisors, canines, and premolars, as a tape, actively for 10 minutes. Subsequently, all groups will undergo in-office dental whitening treatment with 35% hydrogen peroxide (Whiteness HP, FGM). Sensitivity will be assessed using a form consisting of a visual analog scale (VAS). Patients will be instructed to record tooth sensitivity daily during the 21-day follow-up period. To measure color, the VITA Easyshade spectrophotometer (VITA, Germany) will be used at two time points: at baseline (Ti) and one week after the 3rd whitening session (Tf).
干预措施: Spilanthol-free bioadhesive bioplastic film (Other)
结局指标
主要结局
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
时间窗: immediately after the procedure and during a 21-day treatment period.
The bioadhesive film of Acemella Oleracea (jambu) reduces sensitivity related to teeth whitening with 35% hydrogen peroxide.
次要结局
- Changes in the color of teeth bleached with hydrogen peroxide.(one week after the last whitening session.)
研究者
Jesuína Lamartine Nogueira Araújo
principal researcher
Universidade Federal do Para