PERIodontal Disease, Microbiota and Miscarriage
PERI2M
Status Report on Periodontal Status and Oral Microbiota Women Who Have Suffered Repeated Miscarriages: a Pilot Study
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
November 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
January 8, 2025
January 1, 2025
2.1 years
August 26, 2024
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
average quantity of Porphyromonas gingivalis
estimate the average quantity of Porphyromonas gingivalis (Pg) in saliva patients who have had recurrent miscarriages (3 consecutive miscarriages \< 14 weeks of amenorrhea)
AT INCLUSION = T0
Secondary Outcomes (2)
microbiological composition
AT INCLUSION = T0
microbiological composition
AT INCLUSION = T0
Interventions
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.
Eligibility Criteria
women whom had repeated miscarriages : at least 3
You may qualify if:
- women whom had repeated miscarriages
- at least 6 natural teeth
You may not qualify if:
- under antibiotic prebiotic or probiotics treatment one month prior to the study
- with high infection risk (HIV,...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2024
First Posted
August 29, 2024
Study Start
November 29, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
January 8, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share