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NCT Number: NCT06576622

PERIodontal Disease, Microbiota and Miscarriage

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,...)

Treatment and study plan

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.

Primary outcomes

  1. average quantity of Porphyromonas gingivalis

    Time frame: 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

  1. microbiological composition

    Time frame: 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).

  2. microbiological composition

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

alexia VINEL, md

CONTACT

[email protected]

+33 5 61 32 25 09

stephanie brayer

CONTACT

[email protected]

+33 5 61 32 25 09

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PERI2M

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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