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Prevention of Pre-Term Birth by Treatment of Periodontal Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by King Edward Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133926
First Posted: August 24, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of Western Australia
Information provided by:
King Edward Memorial Hospital
  Purpose
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 Intervention Phase
Periodontal Diseases Premature Birth Pre-Eclampsia Procedure: Treatment of periodontal disease Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by King Edward Memorial Hospital:

Primary Outcome Measures:
  • Rate of pre-term birth

Secondary Outcome Measures:
  • Rate of fetal growth restriction
  • Rate of pre-eclampsia
  • Rate of complications of pre-term birth

Estimated Enrollment: 1094
Study Start Date: March 2005
Estimated Study Completion Date: June 2008
  Show Detailed Description

  Eligibility

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
  Contacts and Locations
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
  More Information

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 Submitted: August 23, 2005
First Posted: August 24, 2005
Last Update Posted: October 12, 2017
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