PERIodontal Disease, Microbiota and Miscarriage (PERI2M)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Miscarriage; Parodontitis
• Intervention / Treatment: Other: biological sampling

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: alexia VINEL, md; Phone Number: +33 5 61 32 25 09; Email: vinel.a@chu-toulouse.fr
• Study Contact Backup: Name: stephanie brayer; Phone Number: +33 5 61 32 25 09; Email: Brayer.Stephanie@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • UH Toulouse
    • Contact: Alexia VINEL; Phone Number: +33 5 61 32 25 09; Email: vinel.c@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women whom had repeated miscarriages : at least 3

Description

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,...)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiological composition	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).	AT INCLUSION = T0
microbiological composition	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.	AT INCLUSION = T0

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Porphyromonas gingivalis; SALIVA; subgingival plaque; REPEATED MISCARRIAGES; BIOLOGICAL SAMPLES
• Additional Relevant MeSH Terms: Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Dry Socket
• Other Study ID Numbers: RC31/24/0053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No