MiscarriagePERI2MNCT06576622
PERIodontal Disease, Microbiota and Miscarriage
An observational study of Miscarriage and Parodontitis, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years, women only
- Conditions the study is for
- Miscarriage, Parodontitis
- What is being tested?
- biological sampling
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: women whom had repeated miscarriages : at least 3
Who may be able to join
- women whom had repeated miscarriages
- at least 6 natural teeth
Who cannot join
- under antibiotic prebiotic or probiotics treatment one month prior to the study
- with high infection risk (HIV,...)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
UH Toulouse
Toulouse
Alexia VINEL, +33 5 61 32 25 09, vinel.c@chu-toulouse.fr
About this study
Official title: 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.
Read the 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
- Being tested
- biological sampling
- Keywords
- REPEATED MISCARRIAGES, Porphyromonas gingivalis, SALIVA, BIOLOGICAL SAMPLES, subgingival plaque
- Medical subject headings
- Abortion, Spontaneous, Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplingOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: AT INCLUSION = T0
Secondary outcomes (2)
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).
Measured: 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.
Measured: AT INCLUSION = T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start29 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576622
- Sponsor's protocol ID
- RC31/24/0053
- Acronym
- PERI2M
- Status last verified
- May 2026
- First submitted
- 26 Aug 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status Report on Periodontal Status and Oral Microbiota Women Who Have Suffered Repeated Miscarriages: a Pilot Study
- ClinicalTrials.gov ID
- NCT06576622
- Acronym / sponsor ID
- PERI2M / RC31/24/0053
- Conditions
- Miscarriage, Parodontitis
- Keywords
- REPEATED MISCARRIAGES, Porphyromonas gingivalis, SALIVA, BIOLOGICAL SAMPLES, subgingival plaque
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- women whom had repeated miscarriages : at least 3
Key inclusion criteria (2 listed)
- women whom had repeated miscarriages
- at least 6 natural teeth
Key exclusion criteria (2 listed)
- under antibiotic prebiotic or probiotics treatment one month prior to the study
- with high infection risk (HIV,...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samplingAs 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. | Other | – |
Primary outcome
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)
2 secondary outcomes
microbiological composition
Time frame: AT INCLUSION = T0
microbiological composition
Time frame: AT INCLUSION = T0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage and Parodontitis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alexia VINEL, md (+33 5 61 32 25 09, vinel.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average quantity of Porphyromonas gingivalis (time frame: AT INCLUSION = T0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.