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Набор по приглашению NCT06980714

Powered vs. Manual Toothbrushing in Stage 3-4 Periodontitis

Без фазы С лечением Periodontitis Dental Plaque Gingival Bleeding

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: Powered, Manual.
Кому может быть актуально
Состояния в реестре: Periodontitis, Dental Plaque, Gingival Bleeding. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis

Обзор

This study compares the effectiveness of powered and manual toothbrushes in reducing gum bleeding and dental plaque in people with stage 3 or 4 periodontitis. All participants are trained to brush for at least two minutes twice a day. The goal is to find out whether using a powered toothbrush leads to better oral hygiene results than a manual one, when brushing time is standardized. The study will measure bleeding and plaque levels at the beginning and over a 6-month period.

Подробное описание

This single-blind, randomized controlled trial evaluates the clinical effectiveness of powered versus manual toothbrushing in patients newly diagnosed with stage 3 or 4 periodontitis. Participants are randomly assigned to one of two groups: powered toothbrush (Oral-B iO6) or manual toothbrush (TePe Select Soft). All participants receive standardized oral hygiene instructions and are instructed to brush twice daily for a minimum of two minutes. Manual brush users are required to use a smartphone app to monitor and record brushing duration. The use of adjunctive oral hygiene aids, such as mouthwash or interdental cleaners, is restricted throughout the study period. The primary clinical outcomes are full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS), measured at baseline and at follow-ups of 7 days, 1 month, 3 months, and 6 months.

Вмешательства

  • Поведенческое Powered
    The intervention involves the use of the Oral-B iO6 powered toothbrush, which provides oscillating-rotating brushing action with personalized feedback via its smart pressure sensor and app integration. Participants in this group are instructed to brush for at least two minutes twice daily. The toothbrush is designed to ensure consistent brushing performance, with real-time feedback on brushing technique and duration, allowing for improved oral hygiene habits. The intervention aims to standardize
  • Поведенческое Manual
    The intervention involves the use of the TePe Select Soft manual toothbrush, which features soft bristles for gentle yet effective plaque removal. Participants in this group are instructed to brush for at least two minutes twice daily, with guidance on proper brushing technique. To ensure compliance with the brushing duration, participants are required to use a smartphone app that tracks and records their brushing sessions. The manual toothbrush allows for participant control over brushing press

Первичные конечные точки

  • Full-Mouth Bleeding Score (FMBS) [Срок оценки: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.]
Вторичные конечные точки (1)
  • Systolic and Diastolic Blood Pressure (SBP and DBP) [Срок оценки: SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.]

Критерии участия

Критерии включения

  • Adults aged 18 to 75 years
  • Diagnosis of stage 3 or 4 periodontitis based on clinical and radiographic examination
  • Retaining at least 16 natural teeth
  • Ability to follow oral hygiene instructions and compliance with the study protocol
  • Willingness to refrain from using additional oral hygiene products (e.g., mouthwash, interdental cleaners) during the study
  • Ability to provide informed consent

Критерии исключения

  • Presence of systemic conditions that may affect oral health (e.g., uncontrolled diabetes, immunocompromised states)
  • Pregnancy or breastfeeding
  • Ongoing use of antibiotics or other medications that could interfere with gum health
  • Severe dental conditions (e.g., tooth mobility > 2, advanced root resorption)
  • Prior use of a powered toothbrush within the last 6 months
  • Participation in another clinical trial that could interfere with study outcomes
  • Inability or unwillingness to comply with study requirements or provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Италия · 1 центр
  • University of L'Aquila — L’Aquila

Идентификаторы

NCT: NCT06980714 · Verb n. 25 del 14/09/22 Addend

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗