PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions.
- Кому может быть актуально
- Состояния в реестре: White Spot Lesions. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE: CLINICAL TRIAL
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions
Whitening treatment with 10% carbamide peroxide on teeth with white spot lesions. Assess patient satisfaction with the masking of white spot lesions and the occurrence of tooth sensitivity and gingival irritation.
Первичные конечные точки
- Degree of satisfaction with whitening on white spot lesions [Срок оценки: 2 weeks]
Вторичные конечные точки (4)
- Effectiveness of masking white spot lesions [Срок оценки: 2 weeks]
- EVALUATION OF DENTAL SENSITIVITY [Срок оценки: 2 weeks]
- EVALUATION OF GINGIVAL IRRITATION [Срок оценки: 2 weeks]
- EVALUATION OF THE APPEARANCE OF NEW SPOTS [Срок оценки: 2 weeks]
Критерии участия
Критерии включения
- Be over 18 years of age.
- Have white spots on teeth between 1.3 and 2.3 or between 3.3 and 4.3.
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- Universidad Rey Juan Carlos — Alcorcón
Идентификаторы
NCT: NCT07247760 · URJC_IDIBO_5