Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Patient-Reported Probiotic Use During Periodontal Therapy in Periodontitis

27 de mayo de 2026 actualizado por: Merve Can, Medipol University

Patient-Reported Probiotic Use During Non-Surgical Periodontal Therapy in Stage III Grade B Periodontitis: Clinical Findings, Oral Health Impact and Behavioral Correlates

Most previous studies have evaluated standardized probiotic regimens as adjuncts to NSPT (Ausenda et al., 2023; Hardan et al., 2022; Mauriello et al., 2025). Less is known about how real-world probiotic product use during periodontal care relates simultaneously to clinical outcomes, OHRQoL and patient-level behavioral factors such as knowledge, acceptance, previous recommendation and product/form preferences. Therefore, the aim of this prospective observational study was to compare periodontal clinical and OHRQoL outcomes at 1 and 3 months after NSPT between patients with Stage III Grade B periodontitis who reported probiotic supplement or commercially labelled probiotic product use and those who reported no such use. A secondary aim was to evaluate whether pre-treatment probiotic knowledge/familiarity, attitudes, previous probiotic recommendation, acceptance profile and product/form preferences were associated with reported probiotic product use.

This study hypothesized that reported probiotic product use during the NSPT period would be associated with lower short-term periodontal burden and better OHRQoL outcomes, and that pre-treatment probiotic familiarity and acceptance would be associated with reported use.

Descripción general del estudio

Descripción detallada

This study included 130 stage 3 grade b periodontitis patients, classified as self-reported probiotic product users or non-users (n = 65 each). Periodontitis was defined by detectable interdental CAL at two or more non-adjacent teeth. Stage III Grade B periodontitis was defined by interdental CAL ≥5 mm at the site of greatest loss, with grading based on a bone loss/age ratio of 0.25-1.00.

All patients received routine non surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated.

The study did not include an investigator-assigned probiotic intervention. No probiotic strain, dose, formulation, frequency, duration or adherence protocol was prescribed as part of the study. Group classification was based on self-reported use of probiotic supplements or commercially labelled probiotic products during active periodontal treatment and post-treatment follow-up. Patients who reported such use were classified as probiotic product users, whereas those reporting no probiotic supplement or commercially labelled probiotic product use during the same interval were classified as non-users. Traditional homemade fermented foods, including homemade yogurt, kefir, pickles, vinegar, sourdough products and boza, were recorded as dietary fermented-food habits when reported but were not used to define probiotic exposure because strain composition, colony-forming unit content, microbial viability, dose and consistency of intake could not be verified (FAO/WHO, 2002; Hill et al., 2014; Sahin, 2026). Therefore, the exposure represented self-reported real-world probiotic-labelled product use rather than standardized probiotic intake.

Plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), sites with PPD ≥5 mm and the 14-item Oral Health Impact Profile (OHIP-14) were recorded at baseline, 1 month and 3 months. Probiotic-related knowledge,attitudes and acceptance were assessed using questionnaires.

Tipo de estudio

De observación

Inscripción (Actual)

130

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

    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota School of Dentistry

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with stage 3 grade b periodontitis who applied to the Periodontology Department of Istanbul Medipol University Faculty of Dentistry

Descripción

Inclusion Criteria:

Adults aged 18-70 years. Presence of at least 20 natural teeth. Diagnosis of Stage III Grade B periodontitis. Periodontitis defined as detectable interdental clinical attachment loss at two or more non-adjacent teeth.

Stage III periodontitis defined as interdental clinical attachment loss ≥5 mm at the site of greatest loss.

Grade B periodontitis defined by a bone loss/age ratio of 0.25-1.00. Availability for baseline, 1-month, and 3-month clinical and questionnaire evaluations.

Exclusion Criteria:

Use of systemic antibiotics within the previous 3 months. Periodontal treatment within the previous 6 months. Presence of systemic disease. Pregnancy or lactation. Severe cognitive or psychiatric conditions that could interfere with questionnaire completion or 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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Self-reported probiotic product users with periodontitis
Stage 3 Grabe B Periodontitis patients who reported such use were classified as probiotic product users. All patients received routine non-surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated. Eligible participants were 18-70 years of age, had at least 20 natural teeth, were diagnosed with Stage III Grade B periodontitis and were available for baseline, 1-month and 3-month evaluations. Patients were excluded if they had used systemic antibiotics within the previous 3 months, had received periodontal treatment within the previous 6 months, had systemic disease, were pregnant or lactating, or had severe cognitive or psychiatric conditions that could interfere with questionnaire completion or follow-up.
All patients received routine NSPT, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated (Herrera et al., 2020; Suvan et al., 2020). All NSPT procedures were performed by the same periodontist (M.C.).
Otros nombres:
  • non surgical periodontal treatment
Non-users probiotic with periodontitis
Stage 3 Grabe B Periodontitis patients who those reporting no probiotic supplement or commercially labelled probiotic product use during the same interval were classified as non-users. All patients received routine non-surgical periodontal therapy, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated. Eligible participants were 18-70 years of age, had at least 20 natural teeth, were diagnosed with Stage III Grade B periodontitis and were available for baseline, 1-month and 3-month evaluations. Patients were excluded if they had used systemic antibiotics within the previous 3 months, had received periodontal treatment within the previous 6 months, had systemic disease, were pregnant or lactating, or had severe cognitive or psychiatric conditions that could interfere with questionnaire completion or follow-up.
All patients received routine NSPT, including individualized oral hygiene instruction and supra- and subgingival mechanical debridement/root surface instrumentation where indicated (Herrera et al., 2020; Suvan et al., 2020). All NSPT procedures were performed by the same periodontist (M.C.).
Otros nombres:
  • non surgical periodontal treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Silness and Löe Plaque Index Score
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Plaque accumulation will be assessed using the Silness and Löe Plaque Index during clinical periodontal examination with a Williams periodontal probe. Plaque will be scored from 0 to 3 at the gingival margin, with higher scores indicating greater plaque accumulation. The outcome will be expressed as the mean plaque index score per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Percentage of Bleeding Sites
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Bleeding on probing will be assessed using a Williams periodontal probe and recorded dichotomously as present (+) or absent (-) at each periodontal site within 10 seconds after gentle probing. The outcome will be expressed as the percentage of bleeding sites per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Probing Pocket Depth in Millimeters
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Probing pocket depth will be measured in millimeters (mm) using a Williams periodontal probe as the distance from the gingival margin to the base of the periodontal pocket. The outcome will be expressed as the mean probing pocket depth per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in Clinical Attachment Level in Millimeters
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Clinical attachment level will be measured in millimeters (mm) using a Williams periodontal probe as the distance from the cemento-enamel junction to the base of the periodontal pocket. The outcome will be expressed as the mean clinical attachment level per patient.
before treatment, 1 month and 3 months after treatment
Change from Baseline in 14-item Oral Health Impact Profile Total scores
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile questionnaire. Each item will be scored on a 1-to-5 Likert scale, and the total OHIP-14 score will be calculated by summing all item scores. The outcome will be expressed as a total score ranging from 14 to 70, with higher scores indicating poorer oral health-related quality of life.
before treatment, 1 month and 3 months after treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants with Probiotic Familiarity
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Probiotic familiarity will be assessed using an investigator-developed structured questionnaire evaluating whether participants have previously heard of probiotics or are familiar with probiotic products. The outcome will be expressed as the percentage of participants giving affirmative responses to probiotic familiarity items.
before treatment, 1 month and 3 months after treatment
Percentage of Participants Reporting Positive Attitudes Toward Probiotics
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Probiotic-related attitudes will be assessed using an investigator-developed structured questionnaire evaluating participants' perceptions of the potential benefits of probiotics for oral and periodontal health. The outcome will be expressed as the percentage of participants giving affirmative responses to positive attitude items.
before treatment, 1 month and 3 months after treatment
Percentage of Participants Accepting Probiotic Use as an Adjunct to Periodontal Care
Periodo de tiempo: before treatment, 1 month and 3 months after treatment
Probiotic acceptance will be assessed using an investigator-developed structured questionnaire evaluating participants' willingness to use probiotic products as an adjunct to periodontal treatment. The outcome will be expressed as the percentage of participants reporting acceptance or willingness to use probiotics during periodontal care.
before treatment, 1 month and 3 months after treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Alpdogan Kantarci, University of Minnesota

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

20 de diciembre de 2025

Finalización primaria (Actual)

25 de abril de 2026

Finalización del estudio (Actual)

30 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

Suscribir