Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

Официальное название

A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.

Обзор

The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.

Подробное описание

This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.

3 visits are planned:

* Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally * Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth) * Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)

Вмешательства

• Другое Test interdental brush
  Interdental brush to be used twice a day during the whole study.
• Другое Comparative interdental brush
  Interdental brush to be used twice a day during the whole study.

Первичные конечные точки

• Effect on dental plaque [Срок оценки: Change from Visit 1 (Day 1) to Visit 2 (Day 29).]
• Effect on gingival bleeding [Срок оценки: Change from Visit 1 (Day 1) to Visit 2 (Day 29).]
• Effect on pocket depth [Срок оценки: Change from Visit 1 (Day 1) to Visit 2 (Day 29).]
• Interdental hygiene assessment by subject [Срок оценки: Visit 2 (Day 29).]
• Adverse events recording [Срок оценки: From Visit 1 (Day 1) to Visit 2 (Day 29)]
• Acceptability Questionnaire assessment [Срок оценки: Visit 2 (Day 29)]

Критерии участия

Критерии включения

• Subject aged between 18 and 80 years included
• Subject having signed his/her written informed consent for his/her participation in the study
• Subject diagnosed with active generalized periodontal disease (excluding gingivitis)
• Subject having at least 20 natural teeth (10 teeth on each side (right and left))

Non-inclusion criteria:

• Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire
• For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
• Subject having any other oral condition than periodontal disease (ex: dermatologic ulcers), or any orthodontic conditions liable to interfere with the study assessment or considered by the investigator hazardous for the subject or incompatible with study requirements
• Systemic treatment or topical treatment/product currently taken/applied in the mouth liable to interfere with study assessments according to the investigator or planned to be taken/applied during the study
• Subject has received periodontal therapy (scaling, root planing, surgery, etc.) within 2 months before the inclusion
• Subject who has undergone oral or gum surgery within 2 months before the inclusion, or planned to be performed during the study

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

Профилактика

Центры проведения

Бельгия · 1 центр

• Cliniques universitaires Saint-Luc — Brussels

Идентификаторы

NCT: NCT07575997 · PR52952025001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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