Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

Periodontal Disease Clinical Trial

Official title:

Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00982813
• Other study ID #: BRD 09/4-G
• Status: Terminated
• Phase: N/A
• First received: September 22, 2009
• Last updated: October 4, 2013
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women older than 18

• Pre-term birth between 24 and 37 gestational weeks

Exclusion Criteria:

• Patient's opposition

• Delivery before 24 gestational weeks or after 37 gestational weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Premature Birth

Intervention

Other:
• Periodontal screening
Periodontal screening in all patients giving birth between 24 and 37 gestational weeks. Bacteriological sampling in the periodontal pocketing. Search for specific cytokines in the periodontal pocketing. Professional prophylaxis and oral hygiene instruction.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sulcular bleeding index as active disease		one week after delivery	No
Secondary	Plaque index		one week after delivery	No
Secondary	Depth of periodontal pocketing		one week after delivery	No
Secondary	Clinical attachment level		one week after delivery	No
Secondary	Bacterial sampling of gingival crevicular fluid		One week after delivery	No
Secondary	Search for cytokines in the gingival crevicular fluid		one week after delivery	No