Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00133926




Registration number
NCT00133926
Ethics application status
Date submitted
23/08/2005
Date registered
24/08/2005
Date last updated
5/04/2007

Titles & IDs
Public title
Prevention of Pre-Term Birth by Treatment of Periodontal Disease
Scientific title
Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study
Secondary ID [1] 0 0
NHMRC Australia 353577
Secondary ID [2] 0 0
353577
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontal Diseases 0 0
Premature Birth 0 0
Pre-Eclampsia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Treatment of periodontal disease

Treatment: Surgery: Treatment of periodontal disease
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of pre-term birth
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Rate of fetal growth restriction
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Rate of pre-eclampsia
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Rate of complications of pre-term birth
Timepoint [3] 0 0

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2008
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
King Edward Memorial Hospital, Bagot Rd, Subiaco - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
King Edward Memorial Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00133926
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John P Newnham, MD, FRANZCOG
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John P Newnham, MD, FRANZCOG
Address 0 0
Country 0 0
Phone 0 0
61 9 9340 1331
Fax 0 0
Email 0 0
jnewnham@obsgyn.uwa.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00133926