Clinical Study to Evaluate Remineralization Using an in Situ Model. (REMINSITU)
Clinical Study to Evaluate Enamel Remineralization Using Three Dentifrices in an in Situ Model.
Обзор исследования
Статус
Подробное описание
This Phase III, randomized, single-center, triple-blind, crossover clinical study will evaluate the remineralization efficacy of three dentifrices on artificially induced initial enamel caries lesions. The research will involve 30 healthy participants aged 18 to 70 years who meet strict inclusion criteria. The experimental design will utilize an in situ model where participants will wear custom-made removable mandibular intraoral appliances containing four human enamel blocks with pre-formed artificial caries lesions. These lesions will be created laboratory-side using an acidified gel demineralization system before the blocks are mounted into the appliances.
The study will follow a nine-week timeline, divided into three 14-day experimental phases separated by 7-day washout periods to eliminate carryover effects, totaling 8 visits. During the treatment phases, subjects will be randomly assigned to a sequence of three test products: a test dentifrice with 750 ppm MFP, a positive control with 1450 ppm MFP, and a fluoride-free negative control. Each participant will receive a soft-bristle toothbrush and the assigned toothpastes.
The primary outcome will be the change in integrated mineral loss measured by transverse microradiography (TMR). Baseline mineral loss will be established from a slice of each block before intraoral exposure and compared to post-treatment analysis of the adjacent tissue. Secondary outcomes will include changes in lesion depth and fluorescence loss parameters assessed via Quantitative Light-induced Fluorescence (QLF).
Statistical analysis will be performed using a linear mixed-effects ANCOVA model to confirm the hypothesis that the 750 ppm MFP dentifrice promotes significantly greater remineralization than the negative control, with effects lower than or comparable to the high-fluoride positive control.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Fábio Correia Sampaio, PhD
- Номер телефона: +55 83 999821111
- Электронная почта: fabio.correia.sampaio@academico.ufpb.br
Места учебы
-
-
Paraíba
-
João Pessoa, Paraíba, Бразилия, 58.051-900
- Federal University of Paraíba
-
Контакт:
- Fábio Correia Sampaio, PhD
- Номер телефона: +55 83 99982-1111
- Электронная почта: fabio.correia.sampaio@academico.ufpb.br
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Males and females, between 18-70 years of age (inclusive);
- Informed Consent Form signed and availability for the duration of the study;
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history;
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars);
- Normal salivary flow;
- Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.
Exclusion Criteria:
- Oral pathology, chronic disease, or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
- A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm;
- Five or more decayed, untreated dental sites (cavities);
- Current smokers and subjects with a history of alcohol or drug abuse;
- Dental work prevents wearing of the appliance or a reported need to wear a night guard.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Test Group
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush
|
Имеющаяся в продаже зубная щетка с мягкой щетиной для взрослых.
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
|
|
Активный компаратор: Positive Control Group
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush
|
Имеющаяся в продаже зубная щетка с мягкой щетиной для взрослых.
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
|
|
Фальшивый компаратор: Negative Control Group
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush
|
Имеющаяся в продаже зубная щетка с мягкой щетиной для взрослых.
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in integrated mineral loss (Δz)
Временное ограничение: 9 weeks
|
Integrated mineral loss (Δz) will be assessed by transverse microradiography (TMR).
This outcome will evaluate the change from the baseline demineralized state (Δz0) to the post-treatment state (Δz1) to quantify the net mineral gain or loss.
|
9 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in lesion depth
Временное ограничение: 9 weeks
|
Post-treatments lesion depth (LD) will be assessed by TMR.
For each experimental phase, post-treatment values will be compared with corresponding baseline measurements to determine the extent of remineralization.
|
9 weeks
|
|
Change from Baseline in Fluorescence Loss
Временное ограничение: 9 weeks
|
Fluorescence loss ΔF, will be assessed by quantitative light-induced fluorescence (QLF) to measure the percentage loss of fluorescence intensity.
The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
|
9 weeks
|
|
Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks
Временное ограничение: 9 weeks
|
Maximum fluorescence loss ΔFmax at the deepest point of the lesion will be assessed by quantitative light-induced fluorescence (QLF).
The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
|
9 weeks
|
|
Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks
Временное ограничение: 9 weeks
|
Fluorescence loss volume (ΔQ) will be assessed by quantitative light-induced fluorescence (QLF).
The change will be calculated by comparing post-treatment values at 9 weeks with baseline measurements.
|
9 weeks
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Fábio Correia Sampaio, PhD, Federal University of Paraíba
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- CRO-2026-02-REMIN-BZ-CB
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .