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

First Received on September 22, 2009. Last Updated on September 28, 2009 History of Changes

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00982813

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:

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 - French Health Products Safety Agency

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 February 09, 2012