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Идёт набор NCT07069166

Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes

Без фазы С лечением Periodontitis Type 2 Diabetes Mellitus (T2DM)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Para-probiotic oral care, Chlorhexidine oral care.
Кому может быть актуально
Состояния в реестре: Periodontitis, Type 2 Diabetes Mellitus (T2DM). Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Evaluation of Para-Probiotic Toothpaste and Mouthwash on Periodontal Health and Glycemic Control in Diabetic Patients: A Randomized Controlled Trial

Обзор

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule. Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2. The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction. This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.

Вмешательства

  • Препарат Para-probiotic oral care
    This intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health.
  • Препарат Chlorhexidine oral care
    This intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation.

Первичные конечные точки

  • Change in mean Clinical Attachment Level (CAL) [Срок оценки: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
Вторичные конечные точки (5)
  • Change in Bleeding on Probing (BoP) score [Срок оценки: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
  • Change in Probing Pocket Depth (PPD) score [Срок оценки: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
  • Change in Plaque Index (PI) score [Срок оценки: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
  • Change in glycated hemoglobin (HbA1c) level [Срок оценки: Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2)]
  • Change in patient satisfaction score [Срок оценки: 3-month follow-up (T1) and 6-month follow-up (T2)]

Критерии участия

Критерии включения

  • Age between 18 and 70 years
  • Diagnosis of periodontitis (Stage II or III; Grade B or C)
  • Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths
  • Presence of both single- and multi-rooted teeth
  • Type 2 diabetes mellitus diagnosed at least one year prior to enrollment
  • Good general health status and ability to comply with study protocol
  • Written informed consent provided

Критерии исключения

  • Presence of cardiac pacemakers
  • History of neurological disorders
  • History of psychiatric disorders
  • Current pregnancy or breastfeeding
  • Steroid-induced diabetes mellitus
  • Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Италия · 1 центр
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Идентификаторы

NCT: NCT07069166 · 2025-PPDM2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗