CompletedNCT01549587OHMOMUpdated Apr 21, 2023Results posted

Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

An interventional study of 0.243% sodium fluoride and toothbrush in Gingivitis and Pregnancy, sponsored by Procter and Gamble. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-21.

Sponsored by Procter and Gamble · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 746
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

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.

Conditions studied

Gingivitis
Pregnancy

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Gingivitis 609

In context

Gingivitis

609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's enrollment of 746 is above the median of 63 across 494 interventional studies indexed under Gingivitis.

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Lead sponsor

Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 746 participants (actual)

Study arms

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

Interventions

Drug0.243% sodium fluoride
dentifrice: brush thoroughly twice daily
Also known as: Crest® Cavity Protection toothpaste
Devicetoothbrush
brush thoroughly twice daily
Also known as: Oral-B® Indicator toothbrush, regular, soft
Devicedental floss
floss the whole mouth once daily
Also known as: Oral-B® Essentials dental floss
Drug0.454% stannous fluoride
dentifrice: twice daily brush thoroughly for 2 minutes
Also known as: Crest® Pro-Health toothpaste
Devicetoothbrush
twice daily brush thoroughly for 2 minutes
Also known as: Oral-B® ProfessionalCare Series 1000 toothbrush, Oral-B® Precision Clean brush head
Drug0.07% Cetylpyridinium chloride
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
Also known as: Crest® Pro-Health Multi-Protection Mouth Rinse
Devicedental floss
floss the whole mouth once daily
Also known as: Glide® Pro-Health Deep Clean dental floss

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month

Secondary outcomes

Gestational Age (Weeks)
log\[42.9-gestational age\]
Time frame: At delivery

Other outcomes

Neonate Birth Weight (Grams)
Time frame: At delivery
Preterm Birth (Gestational Age < 37 Weeks)
Time frame: At delivery

Results

Posted Oct 19, 2020

Participant flow

Participant flow — Overall Study
Milestone	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Started	373	373
Completed	334	336
Not completed	39	37

Outcome measures

PrimaryChange 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.

Time frame:: 3 months
Reported as:: Least squares mean · score on a scale

Change From Baseline in Löe-Silness Gingivitis Index
score on a scale	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Change From Baseline in Löe-Silness Gingivitis Index	0.141 ± 0.0046	0.154 ± 0.0046

PrimaryChange From Baseline in Löe-Silness Gingivitis Index

Time frame:: 2 months
Reported as:: Least squares mean · score on a scale

Change From Baseline in Löe-Silness Gingivitis Index
score on a scale	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Change From Baseline in Löe-Silness Gingivitis Index	0.124 ± 0.0044	0.137 ± 0.0045

PrimaryChange From Baseline in Löe-Silness Gingivitis Index

Time frame:: 1 month
Reported as:: Least squares mean · score on a scale

Change From Baseline in Löe-Silness Gingivitis Index
score on a scale	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Change From Baseline in Löe-Silness Gingivitis Index	0.112 ± 0.0045	0.125 ± 0.0045

SecondaryGestational Age (Weeks)

log\[42.9-gestational age\]

Time frame:: At delivery
Reported as:: Least squares mean · log weeks

Gestational Age (Weeks)
log weeks	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Gestational Age (Weeks)	1.3988 ± 0.03394	1.3271 ± 0.03403

Other pre-specifiedNeonate Birth Weight (Grams)

Time frame:: At delivery
Reported as:: Least squares mean · grams

Neonate Birth Weight (Grams)
grams	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Neonate Birth Weight (Grams)	3095.97 ± 46.588	3167.80 ± 45.955

Other pre-specifiedPreterm Birth (Gestational Age < 37 Weeks)

Time frame:: At delivery
Reported as:: Count of participants · Participants

Preterm Birth (Gestational Age < 37 Weeks)
Participants	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
Preterm Birth (Gestational Age < 37 Weeks)	32	21

Adverse events

Collected over Participants were enrolled 8-24 weeks into pregnancy until delivery. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Regular Oral Hygiene	0/373 (0%)	79/373 (21.2%)	353/373 (94.6%)
Advanced Oral Hygiene Plus Counseling	0/373 (0%)	75/373 (20.1%)	329/373 (88.2%)

Most frequent serious events

Showing 10 of 71

Most frequent serious events
Event	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
PREMATURE DELIVERYPregnancy, puerperium and perinatal conditions	27/373	15/373
PRE-ECLAMPSIAPregnancy, puerperium and perinatal conditions	21/373	12/373
CHORIOAMNIONITISInfections and infestations	14/373	10/373
PREMATURE RUPTURE OF MEMBRANESPregnancy, puerperium and perinatal conditions	9/373	7/373
GESTATIONAL HYPERTENSIONPregnancy, puerperium and perinatal conditions	8/373	7/373
FOETAL GROWTH RESTRICTIONPregnancy, puerperium and perinatal conditions	1/373	7/373
PREMATURE LABOURPregnancy, puerperium and perinatal conditions	6/373	7/373
STILLBIRTHPregnancy, puerperium and perinatal conditions	4/373	3/373
VAGINAL HAEMORRHAGEReproductive system and breast disorders	4/373	3/373
BLOOD PRESSURE INCREASEDInvestigations	3/373	1/373

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling
STREPTOCOCCUS TEST POSITIVEInvestigations	88/373	94/373
ANAEMIABlood and lymphatic system disorders	35/373	41/373
PREMATURE DELIVERYPregnancy, puerperium and perinatal conditions	40/373	28/373
URINARY TRACT INFECTIONInfections and infestations	27/373	18/373
GESTATIONAL DIABETESPregnancy, puerperium and perinatal conditions	25/373	17/373
CHORIOAMNIONITISInfections and infestations	24/373	22/373
VULVOVAGINAL MYCOTIC INFECTIONInfections and infestations	21/373	24/373
PRE-ECLAMPSIAPregnancy, puerperium and perinatal conditions	23/373	15/373
NAUSEAGastrointestinal disorders	18/373	19/373
VOMITINGGastrointestinal disorders	14/373	19/373

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling	Total
Mean	27.6 ± 5.89	27.4 ± 6.01	27.46 ± 5.945

Sex: Female, Male
Sex: Female, Male(Participants)	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling	Total
Female	373	373	746
Male	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Regular Oral Hygiene	Advanced Oral Hygiene Plus Counseling	Total
American Indian	2	0	2
Asian Oriential	8	15	23
Black	260	262	522
Caucasian	76	77	153
Hispanic	13	10	23
Asian Indian	6	4	10
Multi-racial	8	5	13

Study locations

2 sites

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

References and documents

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 ↗

Study documents

Study protocol · Apr 8, 2013
Statistical analysis plan · Mar 26, 2015

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01549587
Lead sponsor: Procter and Gamble
Responsible party: Sponsor
First posted: Mar 9, 2012
Start date: Feb 2012
Primary completion: Feb 2014
Completion: Apr 2014
Results posted: Oct 19, 2020
Last update: Apr 21, 2023

Study contacts

Marjorie Jeffcoat, DMD

principal investigator · School of Dentistry University of Pennsylvania

Michael Reddy, DMD, DMSc

principal investigator · School of Dentistry University of Alabama

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Tin Fluorides · Cetylpyridinium

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Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)

Study summary

Conditions studied

Browse trials for

In context

Gingivitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria