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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fábio Correia Sampaio, PhD
- Número de teléfono: +55 83 999821111
- Correo electrónico: fabio.correia.sampaio@academico.ufpb.br
Ubicaciones de estudio
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Paraíba
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João Pessoa, Paraíba, Brasil, 58.051-900
- Federal University of Paraíba
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Contacto:
- Fábio Correia Sampaio, PhD
- Número de teléfono: +55 83 99982-1111
- Correo electrónico: fabio.correia.sampaio@academico.ufpb.br
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Test Group
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush
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Un cepillo de dientes de cerdas suaves para adultos disponible comercialmente
Subjects will brush using a fluoride toothpaste containing 750 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
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Comparador activo: Positive Control Group
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush
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Un cepillo de dientes de cerdas suaves para adultos disponible comercialmente
Subjects will brush using a fluoride toothpaste containing 1450 ppm MFP in a Dical base and a soft bristle toothbrush for 14 days
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Comparador falso: Negative Control Group
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush
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Un cepillo de dientes de cerdas suaves para adultos disponible comercialmente
Subjects will brush using a fluoride-free toothpaste in a Dical base and a soft bristle toothbrush for 14 days
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in integrated mineral loss (Δz)
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in lesion depth
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Change from Baseline in Fluorescence Loss
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Change from Baseline in Maximum Fluorescence Loss ΔFmax at 9 Weeks
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Change from Baseline in Fluorescence Loss Volume (ΔQ) at 9 Weeks
Periodo de tiempo: 9 weeks
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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.
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9 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fábio Correia Sampaio, PhD, Federal University of Paraíba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- CRO-2026-02-REMIN-BZ-CB
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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