- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01584479
Periodontal Disease Prevention Study
Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease
This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.
The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.
Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.
To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- Michigan Center for Oral Health Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.
Exclusion Criteria:
- Organ transplant recipients are excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
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Low Risk Experimental Group
1 visit - Low Risk ~1200 subjects - Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
Low risk Control Group
2 visits - Low Risk ~1200 subjects - Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-) |
High Risk Experimental Group
1 visit - High Risk ~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
High Risk Control Group
2 visits - High Risk ~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants With Tooth Loss Over 16 Year Period
Periodo de tiempo: 16 years
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Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.
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16 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in Total Dental Claims During Monitoring Period
Periodo de tiempo: 10 and 15 years
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10 and 15 years
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Change in Total Periodontal Claims During the Monitoring Period
Periodo de tiempo: 10 and 15 years
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10 and 15 years
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Change in Periodontal Surgery Claims
Periodo de tiempo: 10 and 15 years
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10 and 15 years
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Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.
Periodo de tiempo: 10 and 15 years
|
10 and 15 years
|
Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories
Periodo de tiempo: 10 and 15 years
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10 and 15 years
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00037624
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.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Periodontitis
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Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraTerminadoPeriodontitis Agresiva | Periodontitis Del AdultoItalia
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Asem Mohammed Kamel AliTerminadoPatrón Molar-Incisivo Periodontitis Grado C (Periodontitis Agresiva Localizada) | Periodontitis generalizada de grado C (periodontitis agresiva generalizada)Egipto
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Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyDesconocidoPeriodontitis Generalizada del Adulto
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Columbia UniversityTerminadoEnfermedades periodontales | Periodontitis crónica moderada generalizada | Periodontitis crónica severa generalizadaEstados Unidos
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Postgraduate Institute of Dental Sciences RohtakDesconocido
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Aga Khan UniversityTerminadoPeriodontitis Apical CrónicaPakistán
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Government College of Dentistry, IndoreDesconocido
-
Tokat Gaziosmanpasa UniversityTerminadoPeriodontitis Crónica | Periodontitis Agresiva LocalizadaPavo
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PiLeJeTerminadoProbióticos, PeriodontitisFrancia
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Jorge GamonalDesconocidoEficacia de la administración oral de probióticos en pacientes con periodontitis crónica (probiotic)-Periodontitis CrónicaChile