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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03190512
Periodontal Treatment and Psychology
The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.
Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tokat, Pavo, 60250
- Gaziosmanpasa University
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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:
- the presence of periodontal diseases,
- the presence of diagnosed minor depression
- being under maintenance therapy regarding the depression
Exclusion Criteria:
- any hormonal condition such as pregnancy or lactation
- received any periodontal treatment within six months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Test Group
Psychological measurements were taken from periodontal disease patients before treatment and after 6 weeks. Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
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Comparador de placebos: Control Group
Psychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment. Intervention: The Psychological questionnaires were filled. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depression level
Periodo de tiempo: Baseline and after 6 weeks
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The changes in depression level within 6 weeks.
Depression level was determined using the Beck Depression Inventory.
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Baseline and after 6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body image level
Periodo de tiempo: Baseline and after 6 weeks
|
The changes in body image level within 6 weeks.
Body image level was determined using the Body Cathexis Scale.
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Baseline and after 6 weeks
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Anxiety level
Periodo de tiempo: Baseline and after 6 weeks
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The changes in anxiety level within 6 weeks.
Anxiety level was determined using the Beck Anxiety Inventory.
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Baseline and after 6 weeks
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Self-esteem level
Periodo de tiempo: Baseline and after 6 weeks
|
The changes in self-esteem level within 6 weeks.
Self-esteem level was determined using the Rosenberg Self-Esteem Scale.
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Baseline and after 6 weeks
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Probing pocket depth
Periodo de tiempo: Baseline and after 6 weeks
|
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Clinical attachment level
Periodo de tiempo: Baseline and after 6 weeks
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The changes in clinical attachment level after periodontal treatment.
Clinical attachment level was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Gingival index
Periodo de tiempo: Baseline and after 6 weeks
|
The changes in gingival index level after periodontal treatment.
Clinical attachment level was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Plaque index
Periodo de tiempo: Baseline and after 6 weeks
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The changes in plaque index after periodontal treatment.
Plaque index was recorded for determining and classifying oral hygiene status.
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Baseline and after 6 weeks
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Bleeding on probing
Periodo de tiempo: Baseline and after 6 weeks
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The changes in bleeding on probing after periodontal treatment.
Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
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Baseline and after 6 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ozge Gokturk, Gaziosmanpasa Universty
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 14-KAEK-218
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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