GingivitisOHBABYNCT02922010
A Follow-Up Survey of Oral Hygiene and Health Outcomes for Women Previously Enrolled in "OHMOM"
An observational study of Gingivitis, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from the OHMOM study and offspring from that study (NCT01549587) at the University of Alabama Birmingham.
Who may be able to join
- be at least 18 years of age
- sign an informed consent form and be given a copy
- be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study.
Who cannot join
- any medical condition requiring pre-medication prior to dental procedures
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Women's Reproductive Health
Birmingham, Alabama, 35294-0024
About this study
Official title: A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the "OHMOM" Clinical Trial at the University of Alabama Birmingham
The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.
- Conditions
- Gingivitis
- Medical subject headings
- Gingivitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe-Silness Gingivitis Index
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert W Gerlach, DDS, MPH, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922010
- Sponsor's protocol ID
- 2015108
- Acronym
- OHBABY
- Status last verified
- Sep 2017
- First submitted
- 29 Sep 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-Up Survey of Oral Hygiene and Health Outcomes of Women Enrolled in the "OHMOM" Clinical Trial at the University of Alabama Birmingham
- ClinicalTrials.gov ID
- NCT02922010
- Acronym / sponsor ID
- OHBABY / 2015108
- Conditions
- Gingivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess oral health, oral hygiene knowledge, and daily oral hygiene practices of women who participated in a randomized controlled trial (2011001) at University of Alabama Birmingham during the period 2012-2014. Additional objectives of the research include evaluation of possible cultural, biological or other mechanisms for outcomes observed in the OHMOM clinical trial, and oral health screening of children born to mothers during the study for the purposes of understanding possible multigenerational effects of oral hygiene education.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from the OHMOM study and offspring from that study (NCT01549587) at the University of Alabama Birmingham.
Key inclusion criteria (3 listed)
- be at least 18 years of age
- sign an informed consent form and be given a copy
- be a former subject in study 2011001 at University of Alabama Birmingham with a live birth outcome from that study.
Key exclusion criteria (3 listed)
- any medical condition requiring pre-medication prior to dental procedures
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Löe-Silness Gingivitis Index
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
Related trials for Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Gerlach, DDS, MPH study director
Procter and Gamble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis, run by Procter and Gamble at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Löe-Silness Gingivitis Index (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.