Clinical trial NCT06576622: PERIodontal Disease, Microbiota and Miscarriage
Official title: Status Report on Periodontal Status and Oral Microbiota Women Who Have Suffered Repeated Miscarriages: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Miscarriage
Parodontitis
Keywords: REPEATED MISCARRIAGES
Porphyromonas gingivalis
SALIVA
BIOLOGICAL SAMPLES
subgingival plaque
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 30
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women whom had repeated miscarriages : at least 3

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: average quantity of Porphyromonas gingivalis
timeFrame: AT INCLUSION = T0
Secondary outcomes:
measure: microbiological composition
timeFrame: AT INCLUSION = T0
measure: microbiological composition
timeFrame: AT INCLUSION = T0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
References: