Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Ide

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15359324

Publication citations

  1. 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.

Additional files

Editorial Notes