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

Primary Purpose

Periodontal Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Periodontal screening
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital

Outcomes

Primary Outcome Measures

Sulcular bleeding index as active disease

Secondary Outcome Measures

Plaque index
Depth of periodontal pocketing
Clinical attachment level
Bacterial sampling of gingival crevicular fluid
Search for cytokines in the gingival crevicular fluid

Full Information

First Posted
September 22, 2009
Last Updated
October 4, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00982813
Brief Title
Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
Official Title
Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulties of internal organization
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Periodontal screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sulcular bleeding index as active disease
Time Frame
one week after delivery
Secondary Outcome Measure Information:
Title
Plaque index
Time Frame
one week after delivery
Title
Depth of periodontal pocketing
Time Frame
one week after delivery
Title
Clinical attachment level
Time Frame
one week after delivery
Title
Bacterial sampling of gingival crevicular fluid
Time Frame
One week after delivery
Title
Search for cytokines in the gingival crevicular fluid
Time Frame
one week after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri-Jean PHILIPPE, Prof.
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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

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