NCT07355673已完成不适用
A Double Blind Randomized Clinical Trial Comparing the Risk of Gingival Irritation of Two Different Isolation Techniques Performed During In-Office Bleaching
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
The objective of this study was to evaluate if two different isolation techniques used during in-office bleaching influence the risk of gingival irritation. The secondary objectives were to investigate whether the isolation technique affects bleaching efficacy, the occurrence of tooth sensitivity, and the intensity of tooth sensitivity (TS).
详细描述
- Visit 1: Study information and delivery of informed consent. Recording of patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all the patients who meet the inclusion criteria. The impressions will be poured into plaster, and a positioning guide-finder tray will be fabricated for each patient for color measurement.
- Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Two clinicians performed the assigned isolation technique (relative or absolute). Then after a correct isolation the clinicians apply over the buccal surface from premolar to premolar of both arches the bleaching agent (Opalescence Boost 40%, Ultradent Products, South Jordan, USA).Two application of 20 minutes each. Objective examination of gingival tissues was performed visually, documented with photographs, and verified using a periodontal probe. The sensitivity was recorded and patient were given a sensitivity test to record at home. c) Visit 3: One week after the first bleaching session. Color measurement with a spectrophotometer and the positioning guide. In this visit the second bleaching session was done with the same steps as visit 2. d) Visit 4: 15 days after the second bleaching session. Final data collection (color + patients sensitivity test)
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
- Double (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 os systemic pathology
- •Periodontally Healthy
- •No cavities
- •Tooth shade of the canines A2 or darker
排除标准
- •Adhesive restorations or protheses in the anterior region
- •Enamel or dentin alterations
- •Smoking habits
- •Pregnant women
- •Undergone prior bleaching treatment
研究者
Patricia Pereira-Lores
Principal Investigator
University of Santiago de Compostela
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