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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
The University of Western Australia
Information provided by:
King Edward Memorial Hospital Identifier:
First received: August 23, 2005
Last updated: April 4, 2007
Last verified: April 2007
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
Procedure: Treatment of periodontal disease
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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


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

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
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Please refer to this study by its identifier: NCT00133926

Contact: John P Newnham, MD, FRANZCOG 61 9 9340 1331
Contact: Dorota Doherty, PhD 61 9 9340 2222

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   
Contact: Dorota Doherty, PhD    61 8 93401627   
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
Principal Investigator: John P Newnham, MD, FRANZCOG The University of Western Australia
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00133926     History of Changes
Other Study ID Numbers: 353577
NHMRC Australia 353577
Study First Received: August 23, 2005
Last Updated: April 4, 2007

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

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Premature Birth
Hypertension, Pregnancy-Induced
Pregnancy Complications
Mouth Diseases
Stomatognathic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications processed this record on May 24, 2017