NCT01549587

Brief Summary

This study will track changes in oral health in pregnant women. Subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. A comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
746

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

February 28, 2012

Results QC Date

August 31, 2020

Last Update Submit

April 20, 2023

Conditions

GingivitisPregnancy

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline in Löe-Silness Gingivitis Index

    Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.

    3 months

  • Change From Baseline in Löe-Silness Gingivitis Index

    Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.

    2 months

  • Change From Baseline in Löe-Silness Gingivitis Index

    Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.

    1 month

Secondary Outcomes (1)

  • Gestational Age (Weeks)

    At delivery

Other Outcomes (2)

  • Neonate Birth Weight (Grams)

    At delivery

  • Preterm Birth (Gestational Age < 37 Weeks)

    At delivery

Study Arms (2)

Regular Oral Hygiene

ACTIVE COMPARATOR

toothpaste, toothbrush and dental floss

Drug: 0.243% sodium fluorideDevice: toothbrushDevice: dental floss

Advanced Oral Hygiene plus counseling

EXPERIMENTAL

toothpaste, toothbrush, mouth rinse and dental floss plus specialized education

Drug: 0.454% stannous fluorideDevice: toothbrushDrug: 0.07% Cetylpyridinium chlorideDevice: dental floss

Interventions

0.243% sodium fluorideDRUG

dentifrice: brush thoroughly twice daily

Also known as: Crest® Cavity Protection toothpaste
Regular Oral Hygiene
toothbrushDEVICE

brush thoroughly twice daily

Also known as: Oral-B® Indicator toothbrush, regular, soft
Regular Oral Hygiene
dental flossDEVICE

floss the whole mouth once daily

Also known as: Oral-B® Essentials dental floss
Regular Oral Hygiene
0.454% stannous fluorideDRUG

dentifrice: twice daily brush thoroughly for 2 minutes

Also known as: Crest® Pro-Health toothpaste
Advanced Oral Hygiene plus counseling
0.07% Cetylpyridinium chlorideDRUG

mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily

Also known as: Crest® Pro-Health Multi-Protection Mouth Rinse
Advanced Oral Hygiene plus counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • be at least the age of legal consent;
  • be between 8 and 24 weeks of pregnancy;
  • have at least 20 natural teeth;
  • have moderate-to-severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding.

You may not qualify if:

  • evidence of multiple gestations;
  • history of HIV infection, AIDS, autoimmune disease, or diabetes other than gestational diabetes;
  • indication for use of antibiotic pre-medication prior to dental procedures;
  • systemic corticosteroid or immunosuppressive therapy within 1 month of Baseline;
  • severe periodontal disease, rampant untreated dental caries, or other oral conditions that necessitate immediate dental care;
  • ongoing dental care that in the opinion of the investigator could impact study participation;
  • a history of allergies or hypersensitivity to mouth rinse products containing CPC;
  • any disease or condition that in the opinion of the investigator could interfere with the safe completion of the study;
  • randomization to a treatment in study 2011001 during a prior pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Women's Reproductive Health

Birmingham, Alabama, 35294-0024, United States

Location

Penn OB/Gyn and Associates

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Parry S, Jeffcoat M, Reddy MS, Doyle MJ, Grender JM, Gerlach RW, Tanna N, Geisinger ML, Geurs NC, Biggio J. Evaluation of an advanced oral hygiene regimen on maternity outcomes in a randomized multicenter clinical trial (Oral Hygiene and Maternity Outcomes Multicenter Study). Am J Obstet Gynecol MFM. 2023 Aug;5(8):100995. doi: 10.1016/j.ajogmf.2023.100995. Epub 2023 Apr 29.

    PMID: 37127210DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Sodium FluorideDental Devices, Home CareTin FluoridesCetylpyridinium

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDental EquipmentDentistryOral HygienePreventive DentistryEquipment and SuppliesTin CompoundsPyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trial Manager
Organization
Procter & Gamble
combs.cs@pg.com
5136225362

Study Officials

  • Marjorie Jeffcoat, DMD

    School of Dentistry University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Michael Reddy, DMD, DMSc

    School of Dentistry University of Alabama

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 9, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

April 1, 2014

Last Updated

April 21, 2023

Results First Posted

October 19, 2020

Record last verified: 2023-04

Locations

US(2)