Efficacy of an Experimental Gel Based on Libidibia Ferrea on Post-bleaching Tooth Sensitivity
2026年5月19日 更新者:Cecy Martins Silva、Universidade Federal do Para
Efficacy of an Experimental Gel Based on Libidibia Ferrea in Controlling Post-bleaching Tooth Sensitivity: a Randomized Clinical Trial.
This randomized, parallel, single-blind, placebo-controlled clinical trial aims to investigate the effects of an experimental 0.5% Libidibia ferrea gel on the control of post-bleaching tooth sensitivity and its influence on bleaching efficacy.
Seventy-five selected volunteers will be randomly allocated into three groups: CT (placebo gel), KF2 (5% potassium nitrate and 2% sodium fluoride), and JUC (experimental Libidibia ferrea gel).
Each group will receive the corresponding desensitizing treatment, and the assigned product will be actively applied to the labial surfaces of the anterior teeth and the buccal surfaces of the first premolars for 10 minutes.
Subsequently, all groups will undergo an in-office tooth bleaching protocol with 35% hydrogen peroxide, consisting of two sessions with three 15-minute applications each, with a 7-day interval between sessions.
Postoperative sensitivity will be recorded daily by the patients for 14 days using a visual analog scale (VAS), while tooth color will be measured using a spectrophotometer at baseline and one week after the end of treatment.
Data will be subjected to statistical analysis according to sample distribution, with a statistical power of 80% and a significance level of 5%.
研究概览
地位
尚未招聘
详细说明
All groups will undergo in-office tooth bleaching treatment, performed in two sessions with a 7-day interval, according to the steps described below: prophylaxis; application of the desensitizing agent or placebo, according to the assigned group, for 10 minutes; rinsing with water; application of the gingival barrier; application of Whiteness HP 35% bleaching gel for 45 minutes, consisting of three 15-minute applications; final removal of the bleaching gel and gingival barrier, followed by rinsing with water.
A lip retractor will be used during the application of the desensitizing agent or placebo and throughout the bleaching procedure.
The assigned product will be actively applied using a microbrush.
研究类型
介入性
注册 (估计的)
75
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Cecy M Silva
- 电话号码:+55 (91) 3201-7563
- 邮箱:cecymsilva@gmail.com
学习地点
-
-
Pará
-
Belém、Pará、巴西、66075-110
- UFPA
-
接触:
- Federal University of Pará
- 电话号码:55(91) 3201-7390
- 邮箱:ppgo@ufpa.br
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
Good oral hygiene; Absence of active caries lesions; No previous tooth bleaching treatment; Absence of dental hypersensitivity; Not being pregnant; Presence of at least 28 teeth in the oral cavity.
Exclusion Criteria:
Volunteers undergoing orthodontic treatment; Presence of periodontal disease; Dental cracks or fractures; Restorations or prostheses on anterior teeth; Extensive restorations in molars; Gastroesophageal disorders; Severe intrinsic tooth discoloration; Presence of dentin exposure in anterior and/or posterior teeth.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较:Placebo
The placebo group received an application of placebo gel for the control of post-bleaching tooth sensitivity.
|
Before bleaching treatment with 35% hydrogen peroxide, participants in the placebo group received a placebo gel without active ingredients, applied under the same conditions described for the experimental gel.
|
|
有源比较器:KF2 - Potassium nitrate
The KF2 group received an application of 5% potassium nitrate and 2% sodium fluoride for the control of post-bleaching tooth sensitivity.
|
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the KF2 group will receive an application of a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
|
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实验性的:Jucá - Libidibia ferrea gel
The Jucá group received an experimental 0.5% Libidibia ferrea gel for the control of post-bleaching tooth sensitivity.
|
Prior to bleaching treatment with 35% hydrogen peroxide, participants in the Jucá group will receive an application of the experimental 0.5% Libidibia ferrea gel on the labial surfaces of the maxillary and mandibular central incisors, lateral incisors, and canines, and on the buccal surfaces of the maxillary and mandibular premolars, for 10 minutes.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-whitening sensitivity assessment
大体时间:14 days
|
To assess postoperative sensitivity, patients will be instructed to complete a form to record daily tooth sensitivity during the 14-day treatment period, based on their individual perception of pain.
This form will be provided at each bleaching session and returned to the researcher at the following session, that is, one week after each bleaching session.
The assessment form will include a visual analog scale (VAS), consisting of a 10-cm horizontal line with scores of 0 and 10 at its ends, where 0 indicates no sensitivity and 10 indicates severe tooth sensitivity.
Patients will be instructed to draw a vertical mark along the horizontal line of the scale to record the intensity of tooth sensitivity each day.
Subsequently, the distance in millimeters from the zero endpoint will be measured using a millimeter ruler, thereby obtaining the patient's pain intensity score.
|
14 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Color evaluation
大体时间:Baseline (T0) and one week after the second bleaching session (T1)
|
The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used for color measurement.
The evaluated tooth area will be the middle third of the labial surface of the maxillary canines.
To standardize color readings, silicone matrices will be fabricated, with the impression extending from canine to canine.
A window will be created on the labial surface of each canine in the silicone guide using a metal device with a 6-mm diameter, corresponding to the diameter of the spectrophotometer tip.
Thus, the tip of the device will be inserted into the silicone guide to obtain the color parameters.
Subsequently, the color difference between baseline (T0) and one week after the second bleaching session (T1) will be calculated using the CIEDE2000 formula (ΔE00).
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Baseline (T0) and one week after the second bleaching session (T1)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月13日
初级完成 (估计的)
2027年1月30日
研究完成 (估计的)
2027年3月30日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 95040526.4.0000.0018
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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