NCT00066131

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
823

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

August 4, 2003

Last Update Submit

July 24, 2015

Conditions

PeriodontitisInfant, Premature

Outcome Measures

Primary Outcomes (1)

  • Gestational age at birth

    At delivery

Secondary Outcomes (4)

  • Infant birth weight

    At delivery

  • Periodontal probing depth

    29-32 weeks of gestation

  • Clinical attachment loss

    29-32 weeks of gestation

  • Bleeding following periodontal probing

    29-32 weeks

Study Arms (2)

Scaling and root planing

ACTIVE COMPARATOR

Scaling and root planing delivered prior to 21 weeks of gestation.

Procedure: Periodontal scaling and root planingProcedure: Scaling and root planing

Placebo

NO INTERVENTION

Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.

Interventions

Periodontal scaling and root planingPROCEDURE

Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.

Also known as: Deep cleaning
Scaling and root planing
Scaling and root planingPROCEDURE

Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.

Scaling and root planing

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be pregnant in the first 13-16 weeks of gestation as determined by menstrual history and obstetrical ultrasound
  • Be at least 16 years of age
  • Have at least 20 natural teeth,
  • Have bleeding on probing (BOP) on at least 35% of all tooth sites
  • Have 4 or more teeth with pockets greater than or equal to 4 mm and attachment loss greater than or equal to 2 mm

You may not qualify if:

  • Are unable to provide informed consent or are unable to cooperate with the study protocol.
  • May be placed at medical risk as a result of participation (i.e. subjects with hematologic disease or other disorders tha preclude routine non-surgical periodontal therapy).
  • Have multiple fetuses as diagnosed by ultrasound.
  • Require antibiotic prophylaxis for periodontal procedures
  • Require greater than 3 essential dental care visits because of extensive decay and/or broken teeth and are likely to have less than 20 natural teeth following essential dental care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Minnesota School Of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94. doi: 10.1056/NEJMoa062249.

    PMID: 17079762RESULT

MeSH Terms

Conditions

PeriodontitisPremature Birth

Interventions

Root PlaningTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Panos Papapanou, DDS, PhD

    Harlem Hospital

    STUDY DIRECTOR

  • Anthony DiAngelis, DMD

    Hennepin County Medical Center, Minneapolis

    STUDY DIRECTOR

  • William Buchanan, DDS

    Jackson Medical Mall

    STUDY DIRECTOR

  • John Novak, DDS

    University of Kentucky

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2003

First Posted

August 5, 2003

Study Start

March 1, 2003

Primary Completion

December 1, 2005

Study Completion

February 1, 2006

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations

US(1)