PERIodontal Disease, Microbiota and Miscarriage

NCT ID: NCT06576622

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-29
• Study Completion Date: 2026-12-30

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.

Conditions

Miscarriage; Parodontitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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,...)

• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UH Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

alexia VINEL, md

Role: CONTACT

vinel.a@chu-toulouse.fr

+33 5 61 32 25 09

stephanie brayer

Role: CONTACT

Brayer.Stephanie@iuct-oncopole.fr

+33 5 61 32 25 09

Facility Contacts

Alexia VINEL

Role: primary

vinel.c@chu-toulouse.fr

+33 5 61 32 25 09

Other Identifiers

RC31/24/0053

Identifier Type: -

Identifier Source: org_study_id