Recruiting NCT06576622

PERIodontal Disease, Microbiota and Miscarriage

— Observational Miscarriage Parodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: biological sampling.
Who it may be relevant to: Registry conditions: Miscarriage, Parodontitis. Basic parameters: up to 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

Other 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.

Primary outcome measures

average quantity of Porphyromonas gingivalis [Time frame: AT INCLUSION = T0]

Secondary outcome measures (2)

microbiological composition [Time frame: AT INCLUSION = T0]
microbiological composition [Time frame: AT INCLUSION = T0]

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,...)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 1 center

UH Toulouse — Toulouse

Identifiers

NCT: NCT06576622 · RC31/24/0053

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗