Investigation of the effect of treatment of maternal chronic periodontitis on delivery and low birth weight

ISRCTN ISRCTN03350903
DOI https://doi.org/10.1186/ISRCTN03350903
Secondary identifying numbers REC00165
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
15/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Ide
Scientific

GKT
Floor 21, Guy's Tower
London
SE1 9RT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectives4,000 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic periodontitis during pregnancy
Intervention1. Intensive periodontal treatment
2. Standard care
Intervention typeOther
Primary outcome measureProportion of mothers in sample having small babies
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1998
Completion date01/10/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Key inclusion criteria4,000 pregnant women will receive a periodontal examination, from which the 300 most severe cases will be invited to participate in the study.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1998
Date of final enrolment01/10/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

GKT
London
SE1 9RT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/09/2004 Yes No