Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576622
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
PERIodontal Disease Microbiota and Miscarriage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Status Report on Periodontal Status and Oral Microbiota Women Who Have Suffered Repeated Miscarriages a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERI2M
Brief Summary:
Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages at least 3 miscarriagesThe 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
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 miscarriagesThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None