Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00165
Study information
Scientific title
Acronym
Study hypothesis
4,000 women will be examined at an early stage of their pregnancy and the 7.5% with the worst period periodontal condition will be randomly assigned to either intensive periodontal treatment or normal care. Data on pregnancy outcome will be collected for all subjects. The major objective is to establish whether the potential adverse effect of chronic periodontitis on pregnancy outcome can be prevented by treatment during pregnancy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic periodontitis during pregnancy
Intervention
1. Intensive periodontal treatment
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Proportion of mothers in sample having small babies
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
01/10/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
4,000 pregnant women will receive a periodontal examination, from which the 300 most severe cases will be invited to participate in the study.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
300
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1998
Recruitment end date
01/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GKT
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15359324
Publication citations
-
Results
Moore S, Ide M, Coward PY, Randhawa M, Borkowska E, Baylis R, Wilson RF, A prospective study to investigate the relationship between periodontal disease and adverse pregnancy outcome., Br Dent J, 2004, 197, 5, 251-8; discussion 247, doi: 10.1038/sj.bdj.4811620.