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Набор скоро начнётся NCT07166224

The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.

Без фазы С лечением Periodontal Diseases Oral Halitosis

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: Oral-B Powered toothbrush, Dual-Light aPDT Treatment - Lumoral.
Кому может быть актуально
Состояния в реестре: Periodontal Diseases, Oral Halitosis. Базовые параметры: от 60 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
Швеция
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

The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment: a Randomized Controlled Trial.

Обзор

Objective: To compare three different oral hygiene regimens regarding plaque index (PI), bleeding on probing (BOP), the number of deepened periodontal pockets ≥4 mm (PPD), oral halitosis, and changes in oral health-related quality of life (OHRQoL) in an older population with periodontitis stage I-III and mild cognitive impairment. 1. Are there improvements in plaque index (PI), number of bleeding on probing (BOP) sites, number of probing depths (PPD), and intraoral halitosis in the two test groups compared to the control group? 2. Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment? Study design: Type: Randomized controlled trial Duration: 6 months per participant, 2 years in total for data collection Participants: 90 participants divided into Intervention and Control groups Intervention Group A (Lumoral Dual-Light aPDT + Manual Toothbrush) Standardized oral hygiene instructions and the use of a manual toothbrush during the test period, with an adjunctive aPDT device (Lumoral®). Intervention Group B (Oral-B iO Powered Toothbrush) Standardized oral hygiene instructions and the use of an Oral-B iO powered toothbrush during the test period. Control Group Standardized oral hygiene instructions and the use of a manual TePe Select extra soft toothbrush during the test period.

Вмешательства

  • Устройство Oral-B Powered toothbrush
    Intervention Group B: Participants receive standardized oral hygiene instructions and use an Oral-B iO powered toothbrush during the test period. The Oral-B iO is an advanced powered toothbrush that combines oscillating-rotating and micro-vibrating bristle movements with real-time feedback technology. It is CE-marked for home use and designed to improve plaque removal and overall oral hygiene compared to manual toothbrushing. The device incorporates pressure sensors and guided brushing modes t
  • Устройство Dual-Light aPDT Treatment - Lumoral
    Intervention Group A: Participants receive standardized oral hygiene instructions and use only a manual toothbrush during the test period, with the addition of an adjunctive antimicrobial photodynamic therapy (aPDT) device (Lumoral®). The Lumoral® treatment device is a CE-marked antibacterial device intended for home use. It is designed to support the treatment and prevention of oral diseases caused by bacterial biofilms. The device functions by emitting light at a specific wavelength, which a

Первичные конечные точки

  • Change in the amount of dental plaque [Срок оценки: Assessments will be conducted at baseline, at 3 months, and at 6 months.]
  • Change in the amount of gingival bleeding on probing [Срок оценки: Assessments will be conducted at baseline, at 3 months, and at 6 months.]
  • Change in the number of periodontal pockets ≥4 mm in depth [Срок оценки: Assessments will be conducted at baseline, at 3 months, and at 6 months.]
  • MMSE-test [Срок оценки: Baseline]
  • Change in the amount of VSCs in the exhaled air [Срок оценки: Assessments will be conducted at baseline, at 3 months, and at 6 months.]
  • Change in values for the oral health related quality of life instrument OHIP-14 [Срок оценки: Assessments will be conducted from baseline to 6 months.]

Критерии участия

Критерии включения

  • Adults aged ≥60 years
  • ≥15 teeth
  • Diagnosed periodontitis stage I-III
  • MMSE score between 22-28
  • Able to provide informed consent

Критерии исключения

  • Antibiotic use (within 3 months)
  • Lumoral use within 3 months
  • Bisphosphonate medication
  • Immunosuppressive drugs or radiation therapy

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
Фундаментальное исследование

Центры проведения

Швеция · 1 центр
  • Blekinge Tekniska Högskola — Karlskrona

Идентификаторы

NCT: NCT07166224 · BTH-6.1.1-0172-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗