Prevention of Pre-Term Birth by Treatment of Periodontal Disease - Full Text View

Prevention of Pre-Term Birth by Treatment of Periodontal Disease

This study is currently recruiting participants.
Verified by King Edward Memorial Hospital, April 2007

Sponsors and Collaborators:	King Edward Memorial Hospital 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

U.S. FDA Resources

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

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

Study placed in the following topic categories:

Birth Weight

Mouth Diseases

Pregnancy Complications

Eclampsia

Obstetric Labor, Premature

Obstetric Labor Complications

Pre-Eclampsia

Preeclampsia

Body Weight

Periodontal Diseases

Hypertension, Pregnancy-Induced

Pregnancy toxemia /hypertension

Stomatognathic Diseases

Premature Birth

Hypertension

ClinicalTrials.gov processed this record on September 05, 2008