Prevention of Pre-Term Birth by Treatment of Periodontal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by King Edward Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The School of Women's and Infants' Health and the School of Dentistry, Univ West Australia
Information provided by:
King Edward Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00133926
First received: August 23, 2005
Last updated: April 4, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   16 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Women's and Infants' Health and the School of Dentistry, Univ West Australia
Investigators
Principal Investigator: John P Newnham, MD, FRANZCOG The University of Western Australia
  More Information

No publications provided by King Edward Memorial Hospital

Additional 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
Study First Received: August 23, 2005
Last Updated: April 4, 2007
Health Authority: Australia: Human Research Ethics Committee

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:
Eclampsia
Periodontal Diseases
Pre-Eclampsia
Premature Birth
Hypertension, Pregnancy-Induced
Pregnancy Complications
Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications

ClinicalTrials.gov processed this record on April 15, 2014