Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Pregnancy Clinical Trial

— OHMOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549587
• Other study ID #: 2011001
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2023
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Pregnancy

Intervention

Drug:
• 0.243% sodium fluoride
dentifrice: brush thoroughly twice daily

Device:
• toothbrush
brush thoroughly twice daily
• 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

Locations

Country	Name	City	State
United States	Center for Women's Reproductive Health	Birmingham	Alabama
United States	Penn OB/Gyn and Associates	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonate Birth Weight (Grams)		At delivery
Other	Preterm Birth (Gestational Age < 37 Weeks)		At delivery
Primary	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
Primary	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
Primary	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	Gestational Age (Weeks)	log[42.9-gestational age]	At delivery