PERIodontal Disease, Microbiota and Miscarriage

Официальное название

Status Report on Periodontal Status and Oral Microbiota Women Who Have Suffered Repeated Miscarriages: a Pilot Study

Обзор

Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).The information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from Toulouse University Hospital. Saliva and subgingival plaque samples, classically carried out in routine dental surgery as part of the health check-up oral, will be used to carry out bacterial assays.

Подробное описание

Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).The information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from Toulouse University Hospital.

As part of the health check-up oral, Will be taken:

* Salivary samples by sputum (1 per patient). The patient will retain her saliva for 1 minute in the mouth and it will be collected in a sterile bottle (approximately 5 ml). * Samples of subgingival plaque in the periodontal sulcus (assessed during periodontal probing) using sterile paper points (minimum 3 and maximum 10 per patient) inserted for 30 seconds into the periodontal sulcus then put in a tube sterile. The plate collection is done by capillary action on the paper tip, a very small quantity is thus taken.

A collection of the history and disease risk factors will then be carried out. periodontal problems (stress level assessed using the visual analogue scale, history personal and family periodontal diseases, oral hygiene habits, etc.) by a routine care interview, the clinical examination (visual examination and recording of oral and periodontal) and radiological examination.

Вмешательства

• Другое biological sampling
  As part of the health check-up oral, Will be taken: * Salivary samples by sputum. * Samples of subgingival plaque in the periodontal sulcus * A collection of the history and disease risk factors will then be carried out. * periodontal problems by a routine care interview, the clinical examination and radiological examination.

Первичные конечные точки

• average quantity of Porphyromonas gingivalis [Срок оценки: AT INCLUSION = T0]

Вторичные конечные точки (2)

• microbiological composition [Срок оценки: AT INCLUSION = T0]
• microbiological composition [Срок оценки: AT INCLUSION = T0]

Критерии участия

Критерии включения

• women whom had repeated miscarriages
• at least 6 natural teeth

Критерии исключения

• under antibiotic prebiotic or probiotics treatment one month prior to the study
• with high infection risk (HIV,...)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• UH Toulouse — Toulouse

Идентификаторы

NCT: NCT06576622 · RC31/24/0053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗