Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment

Официальное название

Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study

Обзор

Oral dysbiosis systematically develops during orthodontic treatment \[35\]\[36\]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene \[37\]: * A group benefiting from intensive personalised prevention * A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics. Based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined. It was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment

Вмешательства

• Другое Standard Care Arm
  standard care combined with personalised prevention
• Другое standard care combined with personalised prevention
  standard care combined with personalised prevention

Первичные конечные точки

• bacteria in biofilm [Срок оценки: At inclusion]
• bacteria in biofilm [Срок оценки: At 3 months]
• bacteria in biofilm [Срок оценки: At 6 months]
• bacteria in biofilm [Срок оценки: At 9 months]
• bacteria in biofilm [Срок оценки: At 12 months]
• viruses in biofilm [Срок оценки: At inclusion]
• viruses in biofilm [Срок оценки: At 3 months]
• viruses in biofilm [Срок оценки: At 6 months]
• viruses in biofilm [Срок оценки: At 9 months]
• viruses in biofilm [Срок оценки: At 12 months]

Вторичные конечные точки (9)

• patient's satisfaction [Срок оценки: at 12 months]
• measurement of immune response [Срок оценки: At inclusion]
• measurement of immune response [Срок оценки: At 3 months]
• measurement of immune response [Срок оценки: At 6 months]
• measurement of immune response [Срок оценки: At 9 months]
• measurement of immune response [Срок оценки: At 12 months]
• plaque index [Срок оценки: through study completion, an average of 1 year]
• gingival index, [Срок оценки: through study completion, an average of 1 year]
• toothbrush wear [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.

Критерии исключения

• Tobacco;
• Overcrowded restorations, untreated caries,
• lack of tooth mineralisation;
• Medical pathologies;
• Known immunodepression (congenital or acquired);
• Taking a treatment that may induce general immunodepression;
• Taking a probiotic;
• Taking a concomitant treatment that may interact with oral health

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

Другое

Центры проведения

Франция · 2 центра

• Rance Orthodontics Practice — Dinan
• Nice university hospital — Nice

Идентификаторы

NCT: NCT06752902 · 23-AOI-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗