Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
21 de junio de 2017 actualizado por: GlaxoSmithKline
A Clinical Study to Evaluate the Efficacy of Pre-procedural and Pre-surgical Rinsing With an Antimicrobial Agent in Reducing Bacteria in Dental Aerosols and in the Oral Cavity
The primary objective of this study will be to evaluate the effect of two week pre-surgical rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the total number of plaque bacteria in the mouth 3 days post implant surgery.
The study will be conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL) Eastman Dental Institute.
Participants will be those who require a single and simple surgical implant to be placed, and will be recruited from new patient referrals within the Eastman Dental Hospital
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
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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London, Reino Unido, WC1X 8LD
- GSK Investigational Site
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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 64 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18-64 years old.
- Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities in medical history or upon oral examination.
- Absence of any condition that could affect the participant's safety or well being or their ability to understand and follow study procedures and requirements.
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
Dental Health
- Good overall oral health in the opinion of investigator.
- A minimum of 20 permanent teeth.
- Requiring a single and simple implant (single tooth replacement with no bone augmentation required for implant placement).
- Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery visit.
- An employee of the sponsor or the study site or members of their immediate family
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Test product
Mouthwash containing 0.2% w/v Chlorhexidine digluconate
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Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.
Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily.
They will then rinse their mouth thoroughly with water after brushing
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Comparador de placebos: Control
Sodium fluoride toothpaste (Aquafresh Mild & Minty)
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Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily.
They will then rinse their mouth thoroughly with water after brushing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery
Periodo de tiempo: At Day 3
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.
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At Day 3
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)
Periodo de tiempo: At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
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At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7
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Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery
Periodo de tiempo: Up to 7 days post implant surgery
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The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue.
An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube.
The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.
The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery
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Up to 7 days post implant surgery
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Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis
Periodo de tiempo: At Baseline
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Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol.
Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery.
After 30 minutes, the settle plates lids were replaced.
This was repeated during the dental prophylaxis procedure using 5 fresh settle plates.
All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days.
The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation
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At Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
1 de febrero de 2015
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
29 de febrero de 2016
Fechas de registro del estudio
Enviado por primera vez
15 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
15 de diciembre de 2014
Publicado por primera vez (Estimar)
18 de diciembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202200
- 2014-003222-40 (Número EudraCT)
- RH02604 (Otro identificador: GSK)
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