GingivitisOHMOMNCT01549587

Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

A study testing 0.243% sodium fluoride, toothbrush and dental floss in people with Gingivitis and Pregnancy, run by Procter and Gamble at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Gingivitis, Pregnancy
What is being tested?: 0.243% sodium fluoride, toothbrush and dental floss
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 746 participants
Where: 2 sitesUnited States
Study dates: Feb 2012to Apr 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

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.

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Women's Reproductive Health
Birmingham, Alabama, 35294-0024
Penn OB/Gyn and Associates
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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
Being tested: 0.243% sodium fluoride, toothbrush, dental floss, 0.454% stannous fluoride, 0.07% Cetylpyridinium chloride
Medical subject headings: Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.243% sodium fluorideDrug
Also called Crest® Cavity Protection toothpaste
dentifrice: brush thoroughly twice daily
toothbrushDevice
Also called Oral-B® Indicator toothbrush, regular, soft
brush thoroughly twice daily
dental flossDevice
Also called Oral-B® Essentials dental floss
floss the whole mouth once daily
0.454% stannous fluorideDrug
Also called Crest® Pro-Health toothpaste
dentifrice: twice daily brush thoroughly for 2 minutes
toothbrushDevice
Also called Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
twice daily brush thoroughly for 2 minutes
0.07% Cetylpyridinium chlorideDrug
Also called Crest® Pro-Health Multi-Protection Mouth Rinse
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
dental flossDevice
Also called Glide® Pro-Health Deep Clean dental floss
floss the whole mouth once daily

Study groups in NCT01549587
Study group	Role	What they receive
Regular Oral Hygiene	Active comparator	toothpaste, toothbrush and dental floss Receives: Drug: 0.243% sodium fluoride; Device: toothbrush; Device: dental floss
Advanced Oral Hygiene plus counseling	Experimental	toothpaste, toothbrush, mouth rinse and dental floss plus specialized education Receives: Drug: 0.454% stannous fluoride; Device: toothbrush; Drug: 0.07% Cetylpyridinium chloride; Device: dental floss

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Löe-Silness Gingivitis Index
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.
Measured: 3 months
Change From Baseline in Löe-Silness Gingivitis Index
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.
Measured: 2 months
Change From Baseline in Löe-Silness Gingivitis Index
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.
Measured: 1 month

Secondary outcomes (1)

Gestational Age (Weeks)
log[42.9-gestational age]
Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Apr 2014

First posted9 Mar 2012 (estimated)
Study startFeb 2012
Primary completionFeb 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 746 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01549587
Sponsor's protocol ID: 2011001
Acronym: OHMOM
Status last verified: Apr 2023
First submitted: 28 Feb 2012
Last updated: 21 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Parry S, Jeffcoat M, Reddy MS, Doyle MJ, Grender JM, Gerlach RW, Tanna N, Geisinger ML, Geurs NC, Biggio J. Evaluation of an advanced oral hygiene regimen on maternity outcomes in a randomized multicenter clinical trial (Oral Hygiene and Maternity Outcomes Multicenter Study). Am J Obstet Gynecol MFM. 2023 Aug;5(8):100995. doi: 10.1016/j.ajogmf.2023.100995. Epub 2023 Apr 29.
PubMed 37127210

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01549587
Acronym / sponsor ID: OHMOM / 2011001
Conditions: Gingivitis, Pregnancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 746 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Feb 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 9 Mar 2012 (estimated)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Regular Oral Hygiene	Active comparator	Drug: 0.243% sodium fluoride, Device: toothbrush, Device: dental flosstoothpaste, toothbrush and dental floss
Advanced Oral Hygiene plus counseling	Experimental	Drug: 0.454% stannous fluoride, Device: toothbrush, Drug: 0.07% Cetylpyridinium chloride, Device: dental flosstoothpaste, toothbrush, mouth rinse and dental floss plus specialized education

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.243% sodium fluorideAlso: Crest® Cavity Protection toothpastedentifrice: brush thoroughly twice daily	Drug	Regular Oral Hygiene
toothbrushAlso: Oral-B® Indicator toothbrush, regular, softbrush thoroughly twice daily	Device	Regular Oral Hygiene
dental flossAlso: Oral-B® Essentials dental flossfloss the whole mouth once daily	Device	Regular Oral Hygiene
0.454% stannous fluorideAlso: Crest® Pro-Health toothpastedentifrice: twice daily brush thoroughly for 2 minutes	Drug	Advanced Oral Hygiene plus counseling
toothbrushAlso: Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush headtwice daily brush thoroughly for 2 minutes	Device	Advanced Oral Hygiene plus counseling
0.07% Cetylpyridinium chlorideAlso: Crest® Pro-Health Multi-Protection Mouth Rinsemouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily	Drug	Advanced Oral Hygiene plus counseling
dental flossAlso: Glide® Pro-Health Deep Clean dental flossfloss the whole mouth once daily	Device	Advanced Oral Hygiene plus counseling

Primary outcome

Change From Baseline in Löe-Silness Gingivitis Index
Time frame: 3 months
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.
Change From Baseline in Löe-Silness Gingivitis Index
Time frame: 2 months
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.
Change From Baseline in Löe-Silness Gingivitis Index
Time frame: 1 month
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.

1 secondary outcome

Gestational Age (Weeks)
Time frame: At delivery

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regular Oral Hygiene	373	334
Advanced Oral Hygiene Plus Counseling	373	336

Primary outcome: Change From Baseline in Löe-Silness Gingivitis Index

Time frame: 3 months. Least squares mean (Standard Error). Unit: score on a scale

Measure	Regular Oral Hygiene n = 267	Advanced Oral Hygiene Plus Counseling n = 265
Value	0.141 (0.0046)	0.154 (0.0046)

Population analysed: Numbers indicate participants that were evaluable at 3 months.

Primary outcome: Change From Baseline in Löe-Silness Gingivitis Index

Time frame: 2 months. Least squares mean (Standard Error). Unit: score on a scale

Measure	Regular Oral Hygiene n = 278	Advanced Oral Hygiene Plus Counseling n = 270
Value	0.124 (0.0044)	0.137 (0.0045)

Population analysed: Numbers indicate the participants that were evaluable at 2 months.

Primary outcome: Change From Baseline in Löe-Silness Gingivitis Index

Time frame: 1 month. Least squares mean (Standard Error). Unit: score on a scale

Measure	Regular Oral Hygiene n = 275	Advanced Oral Hygiene Plus Counseling n = 273
Value	0.112 (0.0045)	0.125 (0.0045)

Population analysed: Numbers indicate the participants that were evaluable at 1 month

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were enrolled 8-24 weeks into pregnancy until delivery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regular Oral Hygiene	79 of 373 (21.2%)	353 of 373 (94.6%)	0 of 373
Advanced Oral Hygiene Plus Counseling	75 of 373 (20.1%)	329 of 373 (88.2%)	0 of 373

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37127210Parry S, Jeffcoat M, Reddy MS, Doyle MJ, Grender JM, Gerlach RW, Tanna N, Geisinger ML, Geurs NC, Biggio J. Evaluation of an advanced oral hygiene regimen on maternity outcomes in a randomized multicenter clinical trial (Oral Hygiene and Maternity Outcomes Multicenter Study). Am J Obstet Gynecol MFM. 2023 Aug;5(8):100995. doi: 10.1016/j.ajogmf.2023.100995. Epub 2023 Apr 29.

Related trials for Gingivitis

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

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.

Marjorie Jeffcoat, DMD principal investigator

School of Dentistry University of Pennsylvania

Michael Reddy, DMD, DMSc principal investigator

School of Dentistry University of Alabama

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 0.243% sodium fluoride, toothbrush and dental floss in people with Gingivitis and Pregnancy, run by Procter and Gamble at 2 sites 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 5 inclusion and 9 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Löe-Silness Gingivitis Index (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01549587, which also lists 1 linked publication.

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 21 Apr 2023.