Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066131
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2003-08-04
Brief Title:
Obstetrics and Periodontal Therapy OPT Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Effects of Periodontal Therapy on Preterm Birth
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT
Brief Summary:
The purpose of this study is to determine if non-surgical periodontal gum treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis gum disease
Detailed Description:
Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial Volunteers will be recruited from Hennepin County Medical Center MN the Jackson Medical Mall MS the University of Kentucky and Harlem NY Hospital The incidence of preterm birth is higher at these sites than the national average Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy scaling and root planing either prior to 20 weeks of their pregnancy or soon after delivery All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment All women will also receive essential dental care to restore caries and treat abscessed teeth The primary birth outcome is gestational age at birth and the secondary outcome is birthweight Maternal risk factors for preterm birth andor intrauterine growth restriction will be used as covariates in the data analysis The study will also document the effect of periodontal therapy on immune response systemic markers of inflammation periodontal infection and clinical periodontal measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIDCR-DE014338 | OTHER | NIDCR | None |