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Periodontal Infection and Prematurity Study

Primary Purpose

Periodontal Diseases, Premature Birth

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Scaling and root planing

About this trial

This is an interventional prevention trial for Periodontal Diseases focused on measuring Dental scaling

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Gestational age between 6 and 20 completed weeks Exclusion Criteria: Periodontal treatment during the pregnancy Antibiotic use within 2 weeks of enrollment Use of antimicrobial mouthwash within 2 weeks Multiple gestation Known mitral valve prolapse

Sites / Locations

Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT00116974

First Posted

June 30, 2005

Last Updated

August 12, 2016

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT00116974

Brief Title

Periodontal Infection and Prematurity Study

Official Title

Periodontal Infection and Prematurity Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Terminated

Why Stopped

Protocol Expired. Terminated by IRB

Study Start Date

October 2004 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

5. Study Description

Brief Summary

This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases, Premature Birth

Keywords

Dental scaling

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

Scaling and root planing

Intervention Description

Scaling and root planing

Primary Outcome Measure Information:

Title

Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks

Time Frame

9 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George A Macones, M.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20840689

Citation

Jeffcoat M, Parry S, Sammel M, Clothier B, Catlin A, Macones G. Periodontal infection and preterm birth: successful periodontal therapy reduces the risk of preterm birth. BJOG. 2011 Jan;118(2):250-6. doi: 10.1111/j.1471-0528.2010.02713.x. Epub 2010 Sep 14.

Results Reference

derived

Learn more about this trial

Periodontal Infection and Prematurity Study

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