Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Study Overview
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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.

Official Title
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A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes

Conditions
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Gingivitis, Pregnancy

Intervention / Treatment
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* Drug: 0.243% sodium fluoride
* Device: toothbrush
* Device: dental floss
* Drug: 0.454% stannous fluoride
* Device: toothbrush
* Drug: 0.07% Cetylpyridinium chloride
* Device: dental floss


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular Oral Hygiene<br>toothpaste, toothbrush and dental floss | Drug: 0.243% sodium fluoride<br>* dentifrice: brush thoroughly twice daily<br>* Other names: Crest® Cavity Protection toothpaste;Device: toothbrush<br>* brush thoroughly twice daily<br>* Other names: Oral-B® Indicator toothbrush, regular, soft;Device: dental floss<br>* floss the whole mouth once daily<br>* Other names: Oral-B® Essentials dental floss;|
| Experimental: Advanced Oral Hygiene plus counseling<br>toothpaste, toothbrush, mouth rinse and dental floss plus specialized education | Drug: 0.454% stannous fluoride<br>* dentifrice: twice daily brush thoroughly for 2 minutes<br>* Other names: Crest® Pro-Health toothpaste;Device: toothbrush<br>* twice daily brush thoroughly for 2 minutes<br>* Other names: Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head;Drug: 0.07% Cetylpyridinium chloride<br>* mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily<br>* Other names: Crest® Pro-Health Multi-Protection Mouth Rinse;Device: dental floss<br>* floss the whole mouth once daily<br>* Other names: Glide® Pro-Health Deep Clean dental floss;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 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. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 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. Mild inflammation - slight change in color, slight edema. No bleeding on probing. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age (Weeks) | log[42.9-gestational age] | At delivery |