Does the Use of a 3-mm Extended Tray During an At-home Bleaching Treatment Increases Gingival Irritation Associated With This Procedure in an Adult Patient: Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Objective clinical examination of gingival irritation
研究概览
简要总结
The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.
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 according to the predetermined assignment ( 1mm extended or 3 mm extended bleaching tray). 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). 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 if they had gingival irritation and the degree of dental sensitivity.
Visit 3: First-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 4: Second-week bleaching review. Data collection (gingival irritation + color + sensitivity).
Visit 5: Third-week bleaching review and end of the study. Data collection (gingival irritation + 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 (Care Provider, 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
Conventional Tray (1 mm)
Patients put in their individualized 1 mm bleaching trays the bleaching treatment every day during three weeks.
干预措施: Conventional Tray (1 mm) (Drug)
Extended Tray (3 mm)
Patients put in their individualized 3 mm bleaching trays the bleaching treatment every day during three weeks.
干预措施: Extended Tray (3 mm) (Drug)
结局指标
主要结局
Objective clinical examination of gingival irritation
时间窗: Once a week, during 3 weeks
Clinicians examined visually and with a periodontal probe the gingival tissue.Patients were categorized according to Löe and Silness' gingival index as: G0 (normal gingiva); G1(mild inflammation: slight change in color, slight edema; no bleeding on probing); G2 (moderate inflammation: redness, edema and glazing; bleeding on probing); and G3 (severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding).Patients will a score of 0 during the treatment will be defined as patients with no gingival irritation. The individual highest recorded score will be the grade of gingival irritation.
Subjective questionnaire of gingival irritation
时间窗: Daily, during 3 weeks
Patients should answer daily a dental sensitivity questionnaire. They should mark a "0" if their gingival tissue appeared normal or a "1" If they observed GI, defined as the presence of a white or red layer on the gingiva.Patients who scored "0" during the treatment were classified as individuals without gingival irritation.
次要结局
- Questionnaire of dental sensitivity(Daily, during 3 weeks)
- 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