- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07935421
Periodontitis in Patients With Osteoarthritis
Presence of Periodontitis in Patients With Osteoarthritis
The aim of the study is to determine the prevalence of periodontitis in patients with osteoarthritis. Methods: A case-control study is planned. The research would include patients of the Orthopaedic Clinic, University Hospital Centre Zagreb that have been diagnosed with osteoarthritis (cases). The control group would be patients from the Dental Polyclinic Zagreb, where the research will be conducted. All patients would undergo a dental examination to determine their periodontal status and periodontitis stage. Demographic parameters would include: age, gender, education, alcohol and cigarette consumption, exercise habits, BMI, oral hygiene habits, medication and medical history. Expected results: The aim of the study is to determine if there is a link between periodontitis and osteoarthritis. In patients with osteoarthritis a higher prevalence of periodontitis is expected, as well as more advanced stages of periodontitis, compared to the subjects of the control group. Scientific contribution: The results of the study might further confirm and strengthen the association between periodontitis and osteoarthritis. For the first time the proposed study will explore the presence of five key periodontopathogens in periodontal tissues and synovial fluid patients with periodontitis and osteoarthritis and examine the quality of life related to oral health.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ivana Bradvica
- Número de teléfono: 0038598509914
- Correo electrónico: bradvicaivana@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ivan Puhar
- Número de teléfono: +38598566276
- Correo electrónico: puhar@sfzg.hr
Ubicaciones de estudio
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City of Zagreb
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Zagreb, City of Zagreb, Croacia, 10000
- Reclutamiento
- Medicinski fakultet Sveučilišta u Zagrebu
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Contacto:
- Domagoj Delimar
- Número de teléfono: +385914920501
- Correo electrónico: domagoj.delimar@kbc-zagreb.hr
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Contacto:
- Ivana Bradvica
- Número de teléfono: +38598509914
- Correo electrónico: bradvicaivana@gmail.com
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Zagreb, City of Zagreb, Croacia, 10000
- Reclutamiento
- Stomatološka poliklinika Zagreb
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Contacto:
- Ivan Puhar
- Número de teléfono: +38598566276
- Correo electrónico: puhar@sfzg.hr
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Contacto:
- Ivana Bradvica
- Número de teléfono: +38598509914
- Correo electrónico: bradvicaivana@gmail.com
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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
The research would include patients from the Orthopedic Clinic of the University Hospital Centre Zagreb who have been diagnosed with knee or hip osteoarthritis (study group), and patients from the Dental Polyclinic Zagreb (control group), where the research will also be conducted. Patients would be divided into two subgroups depending on whether they have periodontitis or not.
Descripción
Inclusion Criteria:
Diagnosed primary osteoarthritis of grade 4 according to the Kellgren-Lawrence scale Patients who are independently mobile or mobile with the aid of a walker or forearm crutches Signed informed consent Minimum of twenty teeth in the jaw (third molars are excluded)
Exclusion Criteria:
Use of systemic antibiotics or periodontal therapy performed within the last six months Systemic diseases known to be risk factors for the development of periodontitis (diabetes mellitus, obesity, rheumatoid arthritis, depression, hematological diseases) Secondary osteoarthritis Parkinson's disease Pregnant or breastfeeding women Neoplasms
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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patients with osteoarthritis
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This is an observational study, and participants did not receive any study-specific intervention measures. |
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patients without osteoarthritis
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This is an observational study, and participants did not receive any study-specific intervention measures. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PPD
Periodo de tiempo: Baseline (single assessment)
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Periodontal probing depth - the distance in millimeters from the gingival margin to the base of the periodontal pocket. It is measured using a standard periodontal probe at 6 sites per tooth. Higher values indicate deeper periodontal pockets (worse periodontal status), while lower values indicate shallower pockets (better periodontal status). |
Baseline (single assessment)
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PCR microbiological testing
Periodo de tiempo: Baseline (single assessment)
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PCR test (polymerase chain reaction, 7500 Real-Time PCR System, Applied Biosystems/Method RT-PCR with Sybr-Green/melting curve analysis, validated according to micro-IDent®, Hain Lifescience GmbH, CE-IVD and PeriodontScreen Real-TM CE, Sacace Biotechnologies) is planned for the most common periodontopathogenic bacteria: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythensis, Prevotella intermedia, and Treponema denticola. The test would be taken from all patients in the study group diagnosed with periodontitis. Samples of bacteria would be collected from the periodontal pocket and synovial fluid. When testing bacteria from periodontal pockets, sterile paper points are inserted to the bottom of the deepest pockets and left in situ for 20 seconds. The paper points are then placed in a sterile test tube, tightly closed, and sent to the molecular laboratory of the Analiza Polyclinic. The procedure for collecting bacteria from synovial fluid also include |
Baseline (single assessment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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OHIP-14
Periodo de tiempo: Baseline (single assessment)
|
OHIP-14 is a 14-item questionnaire that assesses the impact of oral health on oral health-related quality of life. Each item is scored on a Likert scale from 0 to 4 (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score ranges from 0 to 56. Higher scores indicate worse oral health-related quality of life, while lower scores indicate better oral health-related quality of life. |
Baseline (single assessment)
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RE
Periodo de tiempo: Baseline (single assessment)
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Gingival recession is the distance in millimeters from the cementoenamel junction to the gingival margin. It is measured using a standard periodontal probe. Higher values indicate more pronounced gingival recession (worse condition), while lower values or a value of 0 indicate a normal position of the gingival margin. |
Baseline (single assessment)
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CAL
Periodo de tiempo: Baseline (single assessment)
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Clinical attachment level is the sum of probing depth and gingival recession at a given tooth site, expressed in millimeters. It represents the distance from the cementoenamel junction to the base of the periodontal pocket. Higher values indicate greater clinical attachment loss (worse condition), while lower values indicate a more preserved periodontal supporting structures. |
Baseline (single assessment)
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FMPS
Periodo de tiempo: Baseline (single assessment)
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Full-mouth plaque score - plaque accumulation will be assessing the presence or absence of supragingival plaque on six surfaces of each tooth. The results will be expressed as the percentage of plaque-positive surfaces relative to the total number of examined surfaces. FMPS is calculated by dividing the number of sites with plaque by the total number of examined sites and multiplying by 100. Scores range from 0% to 100%. Higher percentages indicate greater plaque accumulation (worse condition), while lower percentages indicate better oral hygiene. |
Baseline (single assessment)
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FMBS
Periodo de tiempo: Baseline (single assessment)
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Full-mouth bleeding score - gingival inflammation will be assessed recorded dichotomously (presence/absence of bleeding) following gentle probing of the gingival sulcus at standardized sites. The outcome will be expressed as the percentage of bleeding-positive sites, reflecting the degree of gingival inflammatory response. FMBS is calculated by dividing the number of bleeding sites by the total number of examined sites and multiplying by 100. Scores range from 0% to 100%. Higher percentages indicate greater gingival inflammation (worse condition), while lower percentages indicate healthier gingival tissue. |
Baseline (single assessment)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 05-PA-12-3/2024
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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