PERIodontal Disease, Microbiota and Miscarriage

NCT06576622 — Recruiting, 30 participants, University Hospital, Toulouse

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

RegistryNCT06576622, acronym PERI2M
StatusRecruiting
Study typeObservational
Enrollment30 (Estimated)
SponsorUniversity Hospital, Toulouse (Other)
ConditionsMiscarriage, Parodontitis
Interventionsbiological sampling (Other)
Datesstart 2024-11-29, primary completion 2026-12-30 (estimated), completion 2026-12-30 (estimated), first posted 2024-08-29, last updated 2026-05-12
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Miscarriage All trials for Parodontitis All trials of biological sampling

-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.

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+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.

+Arms and interventions

  • biological sampling (Other): 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.

+Outcome measures

Primary outcomes

  • average quantity of Porphyromonas gingivalis [AT INCLUSION = T0]: estimate the average quantity of Porphyromonas gingivalis (Pg) in saliva patients who have had recurrent miscarriages (3 consecutive miscarriages < 14 weeks of amenorrhea)

Secondary outcomes

  • microbiological composition [AT INCLUSION = T0]: microbiological composition of the saliva in women having had repeated miscarriages : 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).
  • microbiological composition [AT INCLUSION = T0]: microbiological composition of the subgingival plaque in women having had repeated miscarriages 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.

+Eligibility

Sex: Female, ages: any to 18 Years

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,...)

+Locations (1)

FacilityCityCountryStatus
UH ToulouseToulouseFranceRecruiting