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临床试验/NCT07247760
NCT07247760Enrolling By Invitation不适用

PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE: CLINICAL TRIAL

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
67
试验地点
1
主要终点
Degree of satisfaction with whitening on white spot lesions

研究概览

简要总结

The clinical trial aims to evaluate patient satisfaction and the efficacy of home whitening with 10% carbamide peroxide in masking white spot lesions, as well as the presence of sensitivity and gingival irritation.

详细描述

The clinical trial aims to evaluate patient satisfaction and the efficacy of home whitening with 10% carbamide peroxide in masking white spot lesions, as well as the presence of sensitivity and gingival irritation. Patients with at least one white spot due to enamel development defects in any of the anterior teeth will be selected, up to a minimum of 67 lesions. An initial characterisation of the white spot lesions will be performed using different standardised photographs with cross-polarisation filters, fluorescence and transillumination. In addition, mapping will be performed using a spectrophotometer to record the L*a*b* parameters in the lesions and surrounding tissue, and patients will initially respond to a survey on their satisfaction with the lesions (VAS scale) and their impact on psychosocial well-being and oral health-related quality of life (PIDAQ and OHIP-14, respectively). Patients classified for the study will be whitened with 10% carbamide peroxide for 3 hours a day for 4 weeks, or until the desaturation obtained is to their liking, or until the CIELAB L* parameter measurements indicate stabilisation of brightness using the spectrophotometer. During treatment, the presence of sensitivity and irritation will be recorded using a VAS scale. Patients will be reviewed 4 weeks after the end of treatment and will respond again to the questionnaire on satisfaction, psychosocial impact of dental aesthetics and oral quality of life (PIDAQ and OHIP-14), and the lesions will be characterised again. The data obtained on satisfaction, PIDAQ and OHIP-14 surveys will be statistically analysed, as will the colour difference between the lesions and the surrounding tissue enamel at the end of treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be over 18 years of age.
  • Have white spots on teeth between 1.3 and 2.3 or between 3.3 and 4.
  • No previous dental treatment on teeth affected by hypomineralisation lesions.
  • No active caries lesions at any ICDAS II stage on the anterior teeth.
  • Patients with satisfactory oral hygiene and periodontal health, who are not undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes. Patients with recessions without sensitivity are included.

排除标准

  • Patients who have previously undergone whitening treatment (less than 5 years ago).
  • Patients undergoing orthodontic treatment.
  • Patients with a history of trauma to the front teeth.
  • Patients with endodontically treated anterior teeth.
  • Pregnant or breastfeeding patients.
  • Patients who smoke.
  • Patients with periodontal disease.
  • Patients with poor oral hygiene.

结局指标

主要结局

Degree of satisfaction with whitening on white spot lesions

时间窗: 2 weeks

The patient will answer questions using the PIDAQ questionnaire to assess whether they consider their white spot lesions to be masked after the whitening treatment.

次要结局

  • Effectiveness of masking white spot lesions(2 weeks)
  • EVALUATION OF DENTAL SENSITIVITY(2 weeks)
  • EVALUATION OF GINGIVAL IRRITATION(2 weeks)
  • EVALUATION OF THE APPEARANCE OF NEW SPOTS(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Giráldez de Luis

PhD DDS

Universidad Rey Juan Carlos

研究点 (1)

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