Prevention of Pre-Term Birth by Treatment of Periodontal Disease

This study is currently recruiting participants.

Verified by King Edward Memorial Hospital, April 2007

First Received: August 23, 2005 Last Updated: April 4, 2007 History of Changes

Sponsor:	King Edward Memorial Hospital
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

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study

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

Study ID Numbers:	353577, NHMRC Australia 353577
Study First Received:	August 23, 2005
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00133926 History of Changes
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:

Mouth Diseases
Hypertension, Pregnancy-Induced
Periodontal Diseases
Pregnancy Complications
Eclampsia

Obstetric Labor, Premature
Obstetric Labor Complications
Pre-Eclampsia
Stomatognathic Diseases
Premature Birth

ClinicalTrials.gov processed this record on November 27, 2009