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NCT01549587 · ClinicalTrials.gov registry record · NA
Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)
A NA study, sponsored by Procter and Gamble.
- Completed
- Registry status
- NA
- Development phase
- 746
- Enrollment target
NCT01549587: Completed NA study, sponsored by Procter and Gamble.
NCT01549587 is a NA study that has completed, run by Procter and Gamble. The registered enrollment target is 746 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01549587, a NA study, has completed, sponsored by Procter and Gamble.
- COMPLETED
- Registry status
- NA
- Development phase
- 746 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG 0.454% stannous fluoride
- DRUG 0.243% sodium fluoride
- DEVICE toothbrush
- DEVICE dental floss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT01549587 record still lists
NCT01549587 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which 0.454% stannous fluoride is the first listed.
NCT01549587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01549587 about?
NCT01549587 is a clinical study titled "Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)". 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 ...
What is the current status of trial NCT01549587?
This trial is currently completed. It is a NA study. The enrollment target is 746 participants. The study started on 2012-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01549587?
The interventions under investigation include: 0.454% stannous fluoride (DRUG), 0.243% sodium fluoride (DRUG), toothbrush (DEVICE), dental floss (DEVICE).
Who is sponsoring clinical trial NCT01549587?
This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01549587's enrollment target sits among peer trials
746 145th of 2000 higher than 1,856 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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