Assessing Effects of a Denture Gel on Gum Abrasions
A Pilot Clinical Study to Determine the Effect Denture Gel Has on the Prevention of Gum Abrasions
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single center, two-treatment, parallel design study. Up to 40 subjects will be enrolled with a full mandibular and full maxillary denture with a history of food related abrasions.
At each visit, an Oral Soft Tissue exam, a Mucosa Condition Assessment and a Gum Abrasion Evaluation will be performed. At Baseline, the subjects will be randomized to a treatment group. At Baseline, Week 2, and Week 4 subjects will be asked to eat 20 grams of peanuts 4 times for a total consumption of 80 g of peanuts (subjects will be permitted to take breaks if needed and drink small sips of water). Following the peanut challenge, a licensed dental professional will re-evaluate the number and size of abrasions. Subjects will receive a consumer questionnaire to complete as well prior to the Baseline, Week 2, and Week 4 assessments.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Indiana
-
Fort Wayne, Indiana, Estados Unidos, 46825
- Salus Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
In order to be included in the study, each subject must:
- Be 18 years of age;
- Read, sign, and receive a copy of the Informed Consent prior to initiation of study procedures;
- Have a full maxillary and mandibular denture and wear on a daily basis;
- Have a history of food particles getting under their full denture and causing gum irritation;
- Are willing to abstain from eating at least four hours prior to the visits;
- Are willing to eat 4 X 20 grams of peanuts three times (Baseline, Week 2 and Week 4) without denture adhesive;
- Clean their dentures on a daily basis;
- Agree not to change their regular denture cleaning routine;
- Agree to abstain from using denture adhesive during the study;
- Agree to not participate in any other oral/dental product studies during the study.
Exclusion Criteria:
- Exhibit evidence of obvious oral pathology, as determined by the Study Dentist, as a result of a mandatory OST examination on the first day of the study;
- Are allergic to any of the ingredients contained in the study product gel;
- Are allergic to peanuts;
- Wear dentures overnight;
- Are insulin-dependent and/or have any health condition(s) which would prevent compliance with study procedures;
- Are routinely using denture adhesive;
- Present with any disease or conditions that could be expected to increase their susceptibility to gum abrasion (like diabetes or xerostomia); or
- Present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador falso: Grupo de control
|
Subjects will perform their regular denture cleaning routine.
|
|
Experimental: Grupo de prueba
|
In the evening subjects will perform their regular denture cleaning routine.
They will be instructed to sleep without dentures.
Subjects will rinse out their mouth with water (if subjects brush their oral mucosa with brush, they will be allowed to continue doing so) and apply the gel to their mucosa where they normally wear upper or lower denture.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abrasion Assessment (Number)
Periodo de tiempo: Day 3
|
The total number of abrasions pre-food challenge
|
Day 3
|
|
Abrasion Assessment (Size)
Periodo de tiempo: Day 3
|
The average size/area (in mm) of the total number of abrasions pre-food challenge
|
Day 3
|
|
Abrasion Assessment (Number)
Periodo de tiempo: Day 6
|
The total number of abrasions pre-food challenge
|
Day 6
|
|
Abrasion Assessment (Number)
Periodo de tiempo: Week 2
|
The total number of abrasions pre-food challenge
|
Week 2
|
|
Abrasion Assessment (Number)
Periodo de tiempo: Week 4
|
The total number of abrasions pre-food challenge
|
Week 4
|
|
Abrasion Assessment (Size)
Periodo de tiempo: Day 6
|
The average size/area (in mm) of the total number of abrasions pre-food challenge
|
Day 6
|
|
Abrasion Assessment (Size)
Periodo de tiempo: Week 2
|
The average size/area (in mm) of the total number of abrasions pre-food challenge
|
Week 2
|
|
Abrasion Assessment (Size)
Periodo de tiempo: Week 4
|
The average size/area (in mm) of the total number of abrasions pre-food challenge
|
Week 4
|
|
Mucosal Assessment
Periodo de tiempo: Day 3
|
The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy. |
Day 3
|
|
Mucosal Assessment
Periodo de tiempo: Day 6
|
The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy. |
Day 6
|
|
Mucosal Assessment
Periodo de tiempo: Week 2
|
The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy. |
Week 2
|
|
Mucosal Assessment
Periodo de tiempo: Week 4
|
The mucosal region under the denture was assessed with one score per arch (two total arches) each arch is scored ranging from 0(better) - 3(worse). The scores are then summed for a total score. The scale is measured as follows: 0 = pink firm tissue absent of redness and inflammation; 1 = mild redness or inflammation - slight change in color and little change in texture; 2 = moderate redness and/or inflammation - moderate glazing, redness, edema and hypertrophy 3 = severe redness and/or inflammation - marked redness and hypertrophy. |
Week 4
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Otros números de identificación del estudio
- 2020089
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Treatment Gel
-
Medical University of South CarolinaNational Institutes of Health (NIH)Inscripción por invitaciónDe fumar | Dejar de fumar | Trastorno por consumo de tabaco | VIH | SIDA | FarmaciaEstados Unidos
-
University of OklahomaTerminadoAumento de peso | Trastorno de alimentación Neonatal | Lactante de muy bajo peso al nacerEstados Unidos
-
Glyciome, LLCBrigham and Women's Hospital; University of Puerto RicoTerminadoCaracterísticas de percepción sensorial | Aceptabilidad del usuario del sistema de administración de gelEstados Unidos, Puerto Rico
-
Novan, Inc.TerminadoAcné comúnRepública Dominicana, Honduras, Panamá
-
NFlection Therapeutics, Inc.TerminadoNeurofibromatosis 1 | Neurofibroma cutáneoEstados Unidos
-
Starpharma Pty LtdTerminadoVaginosis bacterianaEstados Unidos
-
DermBiont, Inc.Activo, no reclutando
-
NutravaliaSlb PharmaTerminadoSobrepeso y ObesidadFrancia
-
Xinnate ABRegion SkaneTerminadoAmpolla | Epidermólisis Bullosa | Herida de piel | Úlcera varicosa de miembro inferiorSuecia
-
Population CouncilTerminadoInfección por VIHEstados Unidos