Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

746 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingivitis Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Regular Oral Hygiene

toothpaste, toothbrush and dental floss

Group Type ACTIVE_COMPARATOR

0.243% sodium fluoride

Intervention Type DRUG

dentifrice: brush thoroughly twice daily

toothbrush

Intervention Type DEVICE

brush thoroughly twice daily

dental floss

Intervention Type DEVICE

floss the whole mouth once daily

Advanced Oral Hygiene plus counseling

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

Group Type EXPERIMENTAL

0.454% stannous fluoride

Intervention Type DRUG

dentifrice: twice daily brush thoroughly for 2 minutes

toothbrush

Intervention Type DEVICE

twice daily brush thoroughly for 2 minutes

0.07% Cetylpyridinium chloride

Intervention Type DRUG

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

dental floss

Intervention Type DEVICE

floss the whole mouth once daily

Interventions

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0.243% sodium fluoride

dentifrice: brush thoroughly twice daily

Intervention Type DRUG

toothbrush

brush thoroughly twice daily

Intervention Type DEVICE

dental floss

floss the whole mouth once daily

Intervention Type DEVICE

0.454% stannous fluoride

dentifrice: twice daily brush thoroughly for 2 minutes

Intervention Type DRUG

toothbrush

twice daily brush thoroughly for 2 minutes

Intervention Type DEVICE

0.07% Cetylpyridinium chloride

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

Intervention Type DRUG

dental floss

floss the whole mouth once daily

Intervention Type DEVICE

Other Intervention Names

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Crest® Cavity Protection toothpaste Oral-B® Indicator toothbrush, regular, soft Oral-B® Essentials dental floss Crest® Pro-Health toothpaste Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head Crest® Pro-Health Multi-Protection Mouth Rinse Glide® Pro-Health Deep Clean dental floss

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes