NCT00982813

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 7, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

September 22, 2009

Last Update Submit

October 4, 2013

Conditions

Periodontal Disease

Keywords

Periodontal diseasePer-term deliverySulcular bleeding indexBacteriological gingival presenceCytokinesActive periodontal disease with sulcular bleeding indexBacteriological sampling in periodontal pocketingCytokines in the periodontal pocketing

Outcome Measures

Primary Outcomes (1)

  • Sulcular bleeding index as active disease

    one week after delivery

Secondary Outcomes (5)

  • Plaque index

    one week after delivery

  • Depth of periodontal pocketing

    one week after delivery

  • Clinical attachment level

    one week after delivery

  • Bacterial sampling of gingival crevicular fluid

    One week after delivery

  • Search for cytokines in the gingival crevicular fluid

    one week after delivery

Interventions

Periodontal screeningOTHER

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 Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women older than 18
  • Pre-term birth between 24 and 37 gestational weeks

You may not qualify if:

  • Patient's opposition
  • Delivery before 24 gestational weeks or after 37 gestational weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Henri-Jean PHILIPPE, Prof.

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

September 1, 2010

Last Updated

October 7, 2013

Record last verified: 2013-10

Locations

FR(1)