Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis
Clinical, Microbiological and Immunological Effects of the Adjuvant Use of Systemic Antibiotics and Probiotics in the Non-surgical Treatment of Periodontitis: a Controlled and Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Scaling and root planing (SRP) is the most widely used treatment modality in periodontal therapy. However, a subset of periodontal sites does not respond adequately to this approach, and certain individuals exhibit susceptibility patterns that limit their response to initial treatment. Therefore, to overcome the limitations of SRP alone, adjunctive therapies-such as antibiotics and probiotics-may be employed.
The aim of this randomized, controlled, double-blind clinical trial is to evaluate the effects of adjunctive therapies (antibiotics and probiotics) associated with non-surgical periodontal therapy in individuals diagnosed with periodontitis stages III or IV, grades B or C. A total of sixty individuals with a clinical diagnosis of periodontitis will be treated with SRP alone or SRP combined with antibiotics or probiotics. Participants will be randomly allocated into three groups: Control (SRP), Test 1 (SRP + amoxicillin and metronidazole), and Test 2 (SRP + probiotics).
The adjunctive agents evaluated in this study will be a combination of systemic antibiotics (amoxicillin and metronidazole) and the probiotic Bifidobacterium animalis subsp. lactis HN019. Antibiotics will be administered for 14 days, three times daily, whereas probiotics will be administered for 90 days, twice daily. Adjunctive therapies will commence immediately after the first week of periodontal instrumentation.
Clinical follow-up will be conducted at baseline (pre-intervention), and at 3, 6, 9, and 12 months post-treatment. At baseline, 6 months, and 12 months, gingival crevicular fluid, subgingival biofilm, peripheral blood, and fecal samples will be collected, along with the assessment of periodontal clinical parameters. Levels of the cytokines IL-6, TNF-α, IFN-γ, IL-10, IL-1β, and IL-8 will be quantified in gingival crevicular fluid and peripheral blood samples using enzyme-linked immunosorbent assays.
Subgingival biofilm and fecal samples will be subjected to 16S ribosomal RNA gene amplification by PCR and sequenced using Illumina technology (MiSeq or MiniSeq; Illumina, San Diego, CA, USA). Sequencing data will be analyzed using reference databases of the human oral and intestinal microbiomes. Statistical analyses will be performed using an alpha level of 0.05 (p < 0.05).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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São Paulo
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Ribeirão Preto, São Paulo, Brasil, 14040-904
- Universidade de São Paulo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults with a diagnosis of generalized periodontitis, defined as involvement of ≥30% of teeth, classified as: Stage III or Stage IV, and Grade B or Grade C, according to the 2018 classification.
- Presence of at least one tooth with ≥1 interproximal site exhibiting: Probing depth (PD) ≥6 mm, and Clinical attachment loss (CAL) ≥5 mm.
- Presence of at least 15 teeth, excluding third molars and teeth indicated for extraction.
- Presence of at least 6 non contiguous teeth, each with ≥1 interproximal site presenting PD and CAL ≥5 mm.
Exclusion Criteria:
- Current smokers or former smokers who quit less than 5 years prior to enrollment.
- Pregnant or breastfeeding women.
- History of periodontal treatment within the previous 6 months.
- Continuous use of oral antiseptics within the last 6 months.
- Use of systemic antibiotics, corticosteroids, non steroidal anti inflammatory drugs, immunosuppressants, estrogen, estrogen receptor modulators, or medications affecting bone metabolism (e.g., alendronate, calcitonin) within the last 6 months.
- Presence of systemic conditions that may alter the host response, including: Diabetes mellitus, HIV infection, Down syndrome.
- Medical conditions requiring antibiotic prophylaxis for dental procedures (e.g., mitral valve prolapse).
- Known allergy or hypersensitivity to amoxicillin, metronidazole, penicillins, or related compounds.
- Use of probiotics within the last 6 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Placebo
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Experimental: Probiotic
To compare the effects of probiotic as an adjuvant therapy
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Patients will receive probiotic lozenges as an adjuvant therapy to periodontal treatment.
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Experimental: Antibiotic
To compare the effects as an adjuvant therapy
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The antibiotic group will receive amoxicilin and metronidazole, the probiotic group will receive probiotics
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Periodontal Probing Depth (PD)
Periodo de tiempo: every 3 months, up to 1 year
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A full-mouth periodontal examination will be performed using a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA).
Probing depth (PD) will be measured in millimeters at six sites per tooth.
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every 3 months, up to 1 year
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Clinical Attachment Level (CAL)
Periodo de tiempo: Every 3 months, up to 1 year
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Clinical attachment level (CAL) will be measured in millimeters at six sites per tooth using a North Carolina periodontal probe.
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Every 3 months, up to 1 year
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Bleeding on Probing (BOP)
Periodo de tiempo: Every 3 months, up to 1 year
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Bleeding on probing will be assessed dichotomously (presence/absence) at six sites per tooth during full-mouth periodontal examination
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Every 3 months, up to 1 year
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Visible Supragingival Biofilm
Periodo de tiempo: Every 3 months, up to 1 year
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Presence or absence of visible supragingival biofilm will be assessed on four tooth surfaces during full-mouth periodontal examination.
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Every 3 months, up to 1 year
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Distance from Cementoenamel Junction to Gingival Margin
Periodo de tiempo: Every 3 months, up to 1 year
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The distance from the cementoenamel junction to the gingival margin will be measured in millimeters at six sites per tooth.
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Every 3 months, up to 1 year
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Suppuration
Periodo de tiempo: Every 3 months, up to 1 year
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Suppuration will be assessed dichotomously (presence/absence) at six sites per tooth during periodontal examination.
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Every 3 months, up to 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Michel Reis Messora, PhD, University of Sao Paulo
Publicaciones y enlaces útiles
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
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Periodontitis
- Enfermedades periodontales
- Agentes antiinfecciosos
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Imidazoles
- Nitroimidazoles
- Compuestos nitro
- Metronidazol
- Agentes antibacterianos
Otros números de identificación del estudio
- 75898223.7.0000.5419
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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