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

This study has been terminated.
(Difficulties of internal organization)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00982813
First received: September 22, 2009
Last updated: October 4, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


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 ]

Enrollment: 52
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Nantes University Hospital
Nantes, France, 44093
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: October 4, 2013
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 October 19, 2014