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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00982813
First received: September 22, 2009
Last updated: September 28, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Periodontal Disease
 Other: Periodontal screening

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Sulcular bleeding index as active disease [ Time Frame: one week after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plaque index [ Time Frame: one week after delivery ] [ Designated as safety issue: No ]
  • Depth of periodontal pocketing [ Time Frame: one week after delivery ] [ Designated as safety issue: No ]
  • Clinical attachment level [ Time Frame: one week after delivery ] [ Designated as safety issue: No ]
  • Bacterial sampling of gingival crevicular fluid [ Time Frame: One week after delivery ] [ Designated as safety issue: No ]
  • Search for cytokines in the gingival crevicular fluid [ Time Frame: one week after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982813

Contacts
Contact: Henri-Jean PHILIPPE, Prof +33.2.40.08.76.61 henrijean.philippe@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Henri-Jean PHILIPPE, Prof.     +33.2.40.08.76.61     henrijean.philippe@chu-nantes.fr    
Principal Investigator: Henri-Jean PHILIPPE, Prof.            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Henri-Jean PHILIPPE, Prof. Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00982813     History of Changes
Other Study ID Numbers: BRD 09/4-G
Study First Received: September 22, 2009
Last Updated: September 28, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Periodontal disease
Per-term delivery
Sulcular bleeding index
Bacteriological gingival presence
 Cytokines
Active periodontal disease with sulcular bleeding index
Bacteriological sampling in periodontal pocketing
Cytokines in the periodontal pocketing

Additional relevant MeSH terms:
Periodontal Diseases
Premature Birth
Mouth Diseases
Stomatognathic Diseases
 Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on June 17, 2013