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 |
| Protocol serial number | REC00165 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- 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
Scientific
GKT
Floor 21, Guy's Tower
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic periodontitis during pregnancy |
| Intervention | 1. Intensive periodontal treatment 2. Standard care |
| Intervention type | Other |
| Primary outcome measure(s) |
Proportion of mothers in sample having small babies |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 01/10/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
GKT
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
