Bacteremia in Periodontal Patients
11 de agosto de 2014 actualizado por: University of Taubate
Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial
Bacteremia represents the presence of live germs in the blood stream.
Patients with gum disease show damaged tissues and seem to be more susceptible to bacteremia.
In fact, daily activities such as mastication can induce bacteremia in these patients.
Dental procedures related to bleeding also induce bacteremia.
However, there are many questions that should be clarified.
Among them, clinical strategies that are able to reduce the levels of germs in blood should be determined.
This desirable effect could be particularly important for some patients, for example, for those at higher risk for endocarditis.
Therefore, this study tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental instrumentation could reduce the levels of bacteria in the blood.
In addition, the occurrence and magnitude of bacteremia in patients with gum disease were investigated by two different laboratorial techniques.
After receiving verbal and written explanations and after signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth rinse.
In a preliminary visit volunteers underwent a complete periodontal examination which included clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue and dental plaque samples collected with paper points), saliva (to determine volume and biological indicators) and gingival crevicular fluid sampling (to monitor gingival inflammation profile).
In the next visit, dental instrumentation was performed under local anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant.
Blood samples were collected before any dental procedure, 2 and 6 minutes after dental instrumentation.
Oral hygiene instructions and periodontal treatment were performed in additional visits according to individual needs.
Finally, the relation between bacteremia and several indicators of periodontal status was investigated.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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SP
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Taubate, SP, Brasil, 12020330
- Nucleus of periodontal research of University of Taubate
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- mild to moderate plaque related gingivitis (gingivitis group)
- mild to moderate periodontitis (periodontitis group)
- at least 20 natural teeth
- with no recognized systemic risk related to bacteremia
- no need for antibiotic prophylaxis before dental procedures
Exclusion Criteria:
- systemic diseases or other conditions that could influence the periodontal status;
- alcohol or other drugs abuse;
- orthodontic devices;
- extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
- pregnancy or breast-feeding;
- history of sensitivity or suspected allergies following the use of chlorhexidine;
- antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
- regular use of chemotherapeutic antiplaque/antigingivitis products;
- any furcation lesions;
- periodontal treatment performed within six months prior to study initiation;
- unwillingness to return for follow-up.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Experimental: gingivitis mouth rinse
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Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds).
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Experimental: periodontitis mouth rinse
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Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds).
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Comparador activo: gingivitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Comparador activo: periodontitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes on viable bacterial levels in blood
Periodo de tiempo: 2 and 6 minutes
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To check a possible antimicrobial effect after a single mouth rinse use, the levels of viable anaerobic and aerobic bacterial cels were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes.
Blood samples were collected and spread out onto agar plates to determine total levels of aerobic and anaerobic bacteria.
Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.
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2 and 6 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes on levels of bacterial DNA in blood
Periodo de tiempo: 2 and 6 months
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To check a possible antimicrobial effect after a single mouth rinse use, the levels of bacterial DNA in blood samples were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes.
Blood samples were collected and analyzed by real time PCR (polymerase chain reaction) to determine total bacterial load and levels of target periodontal pathogens.
Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.
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2 and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jose R Cortelli, PhD, University of Taubate
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2013
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2014
Primero enviado que cumplió con los criterios de control de calidad
11 de agosto de 2014
Publicado por primera vez (Estimar)
13 de agosto de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de agosto de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Infecciones
- Síndrome de Respuesta Inflamatoria Sistémica
- Inflamación
- Enfermedades Estomatognáticas
- Enfermedades periodontales
- Enfermedades de la Boca
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Septicemia
- Enfermedades gingivales
- Periodontitis
- Gingivitis
- Bacteriemia
- Agentes antiinfecciosos, locales
- Agentes antiinfecciosos
- Agentes dermatológicos
- Desinfectantes
- Clorhexidina
- Gluconato de clorhexidina
Otros números de identificación del estudio
- BPP
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