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Prevention of Pre-Term Birth by Treatment of Periodontal Disease

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ClinicalTrials.gov Identifier: NCT00133926
Recruitment Status : Unknown
Verified April 2007 by King Edward Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 24, 2005
Last Update Posted : April 5, 2007
Sponsor:
Collaborator:
The University of Western Australia
Information provided by:
King Edward Memorial Hospital

Brief Summary:
The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of pregnancy. Dental screening and periodontal treatment protocols have been based on standard techniques employed by hygienists that can be readily applied to the general obstetric population.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Premature Birth Pre-Eclampsia Procedure: Treatment of periodontal disease Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1094 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study
Study Start Date : March 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources




Primary Outcome Measures :
  1. Rate of pre-term birth

Secondary Outcome Measures :
  1. Rate of fetal growth restriction
  2. Rate of pre-eclampsia
  3. Rate of complications of pre-term birth


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women, with single pregnancies, between 12 and 20 weeks gestation
  • Periodontal disease defined as periodontal pocketing at a threshold of 4mm or more at 10% or more of sites
  • Agree to receive periodontal treatment

Exclusion Criteria:

  • Unable to attend for treatment
  • Less than 16 years of age
  • Have a fetus with an abnormality that predisposes the pregnancy to pre-term birth
  • Multiple pregnancy
  • Cardiac disease that would require antibiotic therapy
  • Have fewer than 20 teeth
  • Present for antenatal care after 20 weeks gestation
  • Unable to understand the implications of participation in the trial
  • Currently receiving periodontal treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133926


Contacts
Contact: John P Newnham, MD, FRANZCOG 61 9 9340 1331 jnewnham@obsgyn.uwa.edu.au
Contact: Dorota Doherty, PhD 61 9 9340 2222 ddoherty@obsgyn.uwa.edu.au

Locations
Australia, Western Australia
King Edward Memorial Hospital, Bagot Rd, Subiaco Recruiting
Perth, Western Australia, Australia, 6008
Contact: John P Newnham, MD, FRANZCOG    61 8 93401331    jnewnham@obsgyn.uwa.edu.au   
Contact: Dorota Doherty, PhD    61 8 93401627    ddoherty@obsgyn.uwa.edu.au   
Principal Investigator: John P Newnham, MD, FRANZCOG         
Principal Investigator: John McGeachie, BDSc, PhD         
Principal Investigator: Dorota A Doherty, BSc, PhD         
Principal Investigator: Jon Swain, BDSc         
Sub-Investigator: Ian A Newnham, BDSc, FRACDS         
Sponsors and Collaborators
King Edward Memorial Hospital
The University of Western Australia
Investigators
Principal Investigator: John P Newnham, MD, FRANZCOG The University of Western Australia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00133926     History of Changes
Other Study ID Numbers: 353577
NHMRC Australia 353577
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: April 5, 2007
Last Verified: April 2007

Keywords provided by King Edward Memorial Hospital:
Periodontal disease
Pregnancy
Pre-term birth
Fetal growth
Pre-eclampsia
Infant, Low Birth Weight

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Eclampsia
Pre-Eclampsia
Premature Birth
Mouth Diseases
Stomatognathic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications