A Triple-blind Randomized Clinical Trial Comparing the Efficacy of a Desensitizing Agent Used With an At-home Bleaching Technique
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Questionnaire of dental sensitivity
研究概览
简要总结
The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching.
详细描述
- Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient. A positioning guide tray will be fabricated for color measurement.
- Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products) and one syringe of desensitizing agent (UltraEZ, Ultradent Products) or placebo (glycerin), according to their study group. Both the desensitizing agent and placebo will be dispensed in identical syringes, coded as A and B, to ensure the blinding of the study; only the clinician responsible for randomization knows the coding. Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record the degree of dental sensitivity .
- Visit 3: First-week bleaching review. Data collection (color + sensitivity).
- Visit 4: Second-week bleaching review. Data collection (color + sensitivity).
- Visit 5: Third-week bleaching review and end of the study. Data collection (color + sensitivity).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No oral or systemic pathology
- •Periodontally healthy
- •No cavities
- •Tooth shade of the upper and lower canines A2 or darker
排除标准
- •Adhesive restorations or prostheses in the anterior region
- •Enamel or dentin alterations
- •Pregnant women
- •Undergone prior bleaching treatment
研究组 & 干预措施
UltraEZ Group
Patients put in their bleaching trays the UltraEZ desensitizing gel for 30 minutes before the bleaching treatment every day during three weeks.
干预措施: UltraEZ (Drug)
Placebo Group
Patients put in their bleaching trays the UltraEZ placebo gel for 30 minutes before the bleaching treatment every day during three weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Questionnaire of dental sensitivity
时间窗: Daily, during 3 weeks
Patients should answer a dental sensitivity questionnaire. A a 5-point subjective numerical classification scale will be used (0=no sensitivity, 1=light, 2=mild, 3=considerable and 4=severe). Patients will a score of 0 during the treatment will be defined as patients with no sensitivity. The individual highest recorded score will be the grade of intensity for each patient.
次要结局
- Shade evaluation with a dental spectrophotometer(Once a week, during 3 weeks)
研究者
Patricia Pereira-Lores
Principal Investigator
University of Santiago de Compostela