NCT01549587

Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis
• Pregnancy

Interventions

Type	Name	Description
DRUG	0.243% sodium fluoride	dentifrice: brush thoroughly twice daily
DEVICE	toothbrush	brush thoroughly twice daily
DEVICE	dental floss	floss the whole mouth once daily
DRUG	0.454% stannous fluoride	dentifrice: twice daily brush thoroughly for 2 minutes
DEVICE	toothbrush	twice daily brush thoroughly for 2 minutes
DRUG	0.07% Cetylpyridinium chloride	mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
DEVICE	dental floss	floss the whole mouth once daily

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2012-03-09
• Last updated: 2023-04-21
• Results posted: 2020-10-19

Locations

2 sites across 1 country: United States