Evaluation of the Whitening Effect in Subjects After Professional Tooth Cleaning Procedure

Официальное название

Evaluation of the Effect of a Cosmetic Product for Teeth Care in Maintaining the Whitening Effect of a Professional Dental Cleaning Performed by a Dentist - In Use Test Under Dentist Control Study

Обзор

The goal of this study is to learn if the toothpaste works to maintain effect of the professional tooth cleaning in adults. It will also learn about the safety of the product. The main questions it aims to answer are: • Does the toothpaste help to maintain teeth colour after professional cleaning? Researchers will compare whitening toothpaste to a regular toothpaste to see if it works to maintain effects of professional teeth cleaning. Participants will: * Use assigned toothpaste daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check ups and evaluation

Вмешательства

• Другое Whitening toothpaste
  Subjects will use the whitening toothpaste 3 times daily during 4 weeks
• Другое Regular toothpaste
  Subjects will use the regular toothpaste 3 times daily during 4 weeks

Первичные конечные точки

• Change in teeth colour at by R20 Bleaching guide score at 4 weeks [Срок оценки: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.]

Вторичные конечные точки (1)

• Teeth brightness variation evaluated by score at 4 weeks [Срок оценки: From Baseline (after professional teeth cleaning) to end of use at 4 weeks.]

Критерии участия

Критерии включения

• Healthy 55 subjects
• Subjects of caucasian ethnicity
• Subjects aged between 18 and 65 years (extremes included)
• Subjects clinically showing stains on teeth (due to smoking, tea, coffee, wine or other food that typically stain teeth)
• Subjects having at least one natural teeth or central superior incisors (tooth 11 and 21) with color shade at the inclusion ≥12 and ≤30 according to R20 Bleaching shade guide
• Subjects registered with National Health Service (NHS)
• Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
• Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel
• Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
• Subjects who commit not to change their daily routine or lifestyle during the study
• Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
• Subjects informed about the test procedures who have signed a consent form and privacy agreement

Критерии исключения

• Subjects who do not meet the inclusion criteria.
• Subjects with all affection which could interfere with the interpretation of the results of the study
• Subjects planning toothcare during the study period, using dental apparatus
• Subjects using dental prosthesis affecting the central superior incisors, with generalized tooth recession, malocclusion or overlapping teeth in the anterior region, with presence of caries, with dental abscess or untreated gum disease, with central superior incisor (tooth 11 or 21) evaluated and filled and who performed whitening treatments less than 6 months before the study begin
• Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
• Subjects participating or planning to participate in other clinical trials
• Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
• Subjects that have intolerances or allergies to ingredients of the study product
• Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
• Subjects who are currently using products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
• Subjects admitted to a health or social facility
• Subjects planning a hospitalization during the study
• Subjects not able to be contacted in case of emergency
• Subjects deprived of freedom by administrative or legal decision or under guardianship
• Subjects who have or have had a history of alcohol or drug addiction
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• Clinica Dental Rob — Badalona

Идентификаторы

NCT: NCT07438990 · PIT0000327/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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