- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02954120
Chronic Periodontitis and Polycystic Ovary Syndrome
Evaluation Of Lipid Peroxidation, Oxidative DNA Damage And Total Antioxidant Status In Patients With Periodontitis And Polycystic Ovary Syndrome: A Cross Sectional Study
Background: The aim of this study was to investigate the levels of malondialdehyde (MDA), total antioxidant status (TAS), 8-hydroxy-2´- deoxyguanosine (8-OHdG) in blood serum and saliva samples in female patients with chronic periodontitis (CP) and to compared healthy individuals.
Materials and Methods: A total of 88 women were into four groups each which were consisted of twenty-two subjects. Groups were designed as periodontally and systemically healthy women (PCOS-CP-); periodontally healthy women with polycystic ovary syndrome (PCOS) (PCOS+CP-), systemically healthy women with CP (PCOS-,CP+) and women with PCOS and CP (PCOS+CP+). Serum and salivary samples were obtained, clinical periodontal parameters were recorded. MDA, TAS, 8-OHdG levels were measured as biochemically.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
RESULTS:
Salivary 8-OHdG levels in the PCOSCP and CP groups were statistically higher than those in both the PCOSPH and the PH groups (P < 0.05). There was no statistical difference between the PCOSCP, CP, and PCOSPH groups with regard to salivary MDA and TAS levels (P > 0.05). Highest serum 8-OHdG and MDA levels and lowest serum TAS levels were seen in the PCOSCP group (P < 0.05). Serum 8-OHdG and MDA levels in the PCOSPH group were higher than those in both systemically healthy groups (PH and CP) (P < 0.05). Salivary TAS levels were highest (P < 0.05) in the PH group. There was no statistical difference between the CP and PCOSPH groups, but serum TAS levels were lower than those in the PH group (P < 0.05).
CONCLUSIONS:
CP, which led to an increase in serum and salivary 8-OHdG and MDA levels and a decrease in serum TAS levels in patients with PCOS, contributed to increased OS. This effect was more prominent in serum levels than in salivary levels.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Fatih
-
İstanbul, Fatih, Pavo, 34093
- Department of Periodontics, Faculty of Dentistry, Bezmialem Vakif University
-
-
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:
- Newly diagnosed non-obese PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Exclusion Criteria:
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
- Any drug use within the past 6 months
- Periodontal treatment within the past 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
(PCOS-CP-)
systemically and periodontally healthy participants
|
|
(PCOS-CP+)
systemically healthy participants with CP
|
|
(PCOS+CP-)
PCOS participants with periodontally healthy
|
|
(PCOS+CP+)
PCOS participants with CP
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
8-OHdG levels (nanogram per mililiter(ng/mL))
Periodo de tiempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
MDA levels (micromole per liter (µmol/L))
Periodo de tiempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
TAS levels (millimolar per liter (mmol /L))
Periodo de tiempo: appoximately 2 years
|
by ELISA test
|
appoximately 2 years
|
Plaque Index (PI)
Periodo de tiempo: appoximately 2 years
|
Silnes-Löe Periodondal İndex
|
appoximately 2 years
|
Gingival Index (GI)
Periodo de tiempo: appoximately 2 years
|
Löe-Silness Periodontal Index
|
appoximately 2 years
|
Bleeding on probing (BOP)
Periodo de tiempo: appoximately 2 years
|
Gİngival Bleeding Index
|
appoximately 2 years
|
Clinical attachment level (CAL)
Periodo de tiempo: Patients were seen one time
|
by measuring the distance between the cementoenamel junction and the periodontal pocket base
|
Patients were seen one time
|
Probing pocket depth (PD))
Periodo de tiempo: appoximately 2 years
|
distance between free gingival margin and periodontal pocket base by usin periodontal probe
|
appoximately 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
number of individuals with chronic periodontitis
Periodo de tiempo: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
numberer of individuals with polycystic ovary syndrome
Periodo de tiempo: appoximately 2 years
|
individuals in the group
|
appoximately 2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nesrin Saruhan, PhD, Eskisehir Osmangazi Universitesi
- Director de estudio: Cenk Fatih Çanakcı, Prof, Atatürk Üniversitesi
- Investigador principal: Saime Ozbek Sebin, Dr, Atatürk Üniversitesi
- Investigador principal: Humeyra Canakcı, Dr, Buhara Hastanesi
- Investigador principal: Metin İngeç, Prof, Atatürk Üniversitesi
- Investigador principal: Ufuk Sezer, Phd, Özel Klinik
- Investigador principal: Ebru Saglam, PhD, Saglik Bilimleri Universitesi
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
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedades del sistema endocrino
- Enfermedad
- Quistes en los ovarios
- Quistes
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Enfermedades Estomatognáticas
- Enfermedades periodontales
- Enfermedades de la Boca
- Sindrome de Ovario poliquistico
- Síndrome
- Periodontitis
- Periodontitis Crónica
Otros números de identificación del estudio
- PCOSandCP
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. .
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