- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02612064
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Wirral, Reino Unido, CH41 6EY
- GSK Investigational Site
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Cheshire
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Ellesmere Port, Cheshire, Reino Unido, CH65 4BW
- GSK Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:
A. No clinically significant and relevant abnormalities in medical history or upon oral examination.
B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
- Dental health
At Screening:
A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
B. Good general oral health, with a minimum of 20 natural teeth.
C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
- Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
- Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).
At Baseline:
D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:
- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)
Exclusion Criteria:
- Pregnant or breast feeding women
- Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
- Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
- Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- Any condition which, in the opinion of the investigator, causes xerostomia.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Recent history (within the last year) of alcohol or other substance abuse
- Dental prophylaxis within four weeks of Screening.
- Tongue or lip piercing or presence of dental implants.
- Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
- Teeth bleaching within eight weeks of Screening
- Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
- Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
- Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.
- Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
- Individuals who require antibiotic prophylaxis for dental procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Dentífrico de fluoruro de estaño
Los participantes aplicarán (bajo supervisión) una dosis del tamaño de un guisante de dentífrico experimental que contenga fluoruro de estaño al 0,454 % p/p (1100 ppm) en cada uno de los dos dientes calificados mediante la aplicación directa con el dedo y frotando suavemente el margen cervical del diente durante el tiempo asignado. tiempo.
No se permitirá el enjuague.
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Dentífrico experimental que contiene fluoruro de estaño al 0,454 % p/p (1100 ppm)
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Otro: Dentífrico de monofluorofosfato de sodio
Los participantes aplicarán (bajo supervisión) una dosis del tamaño de un guisante de dentífrico que contenga Dentífrico que contenga monofluorofosfato de sodio al 0,76 % (1000 ppm de fluoruro) en cada uno de los dos dientes calificados mediante la aplicación directa con el dedo y frotando suavemente el margen cervical del diente durante el tiempo asignado .
No se permitirá el enjuague.
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Dentífrico que contiene 0,76 % de monofluorofosfato de sodio (1000 ppm de fluoruro)
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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 From Baseline in Schiff Sensitivity Score on Day 3
Periodo de tiempo: Baseline to 3 days
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The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus.
A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
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Baseline to 3 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
Periodo de tiempo: Baseline to 60 seconds post first treatment
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The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus.
A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
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Baseline to 60 seconds post first treatment
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Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3
Periodo de tiempo: Baseline, 60 seconds post first treatment, Day 3
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The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached.
The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort.
The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold.
The higher the tactile threshold, the less sensitive the tooth.
At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
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Baseline, 60 seconds post first treatment, Day 3
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 205072
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