Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
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: Functionnal test.
- Кому может быть актуально
- Состояния в реестре: Periodontitis, Periodontal Diseases, Quality of Life. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis. Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.
Подробное описание
The questionnaires administered are as follows:
* the EAT-10 (Eating Assessment Tool), used to assess swallowing disorders and the patient's perception of oropharyngeal dysphagia; * the XI (Xerostomia Inventory), used to evaluate xerostomia; * the GOHAI (General Oral Health Assessment Index), used to assess the impact of oral health status on patients' quality of life.
The functional test (masticatory performance "chewing gum" test) will be performed at each visit if applicable (T0, T1, T2) to evaluate the impact of periodontal treatment on masticatory function. The two-colour chewing gum test is a commonly used method for assessing masticatory mixing ability.
Saliva collection for salivary flow analysis will also be performed at each follow-up visit in order to evaluate the impact of periodontal treatment on salivary function.
Вмешательства
- Другое Functionnal test
Administration of questionnaires, functional masticatory test, and saliva collection.
Первичные конечные точки
- The patient's masticatory performance score [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
Вторичные конечные точки (12)
- Severity of periodontal disease assessed by stage. [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Salivation [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Swallowing [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Periodontitis grade (Chicago Classification) [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Gingival recessions [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Plaque Index [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Edentulism [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Bleeding on Probing (BOP) [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Pocket Depth [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Tooth Mobility [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Number of Posterior Functional Dental Units [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
- Oral quality of life [Срок оценки: Baseline (T0), T1 (T0 + 3 month), T2 (end of treatment if complementary treatments are required, assessed no later than 1 year after the start of the initial treatment)]
Критерии участия
Критерии включения
- Patients treated at the university hospital and diagnosed with periodontitis
- Adult patients who have provided informed consent
- Patients enrolled in a social security system
- Patients who speak and understand French.
Критерии исключения
- Minors
- Pregnant or breastfeeding patients
- Patients under legal protection or conservatorship
- Patients who refuse to participate in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Франция · 1 центр
- CHU Clermont-Ferrand — Clermont-Ferrand
Идентификаторы
NCT: NCT07651579 · RBHP 2026 DOUILLARD