Gingivitis, Pregnancy
Conditions
Brief 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.
Interventions
DRUG0.243% sodium fluoride
dentifrice: brush thoroughly twice daily
DEVICEtoothbrush
brush thoroughly twice daily
DEVICEdental floss
floss the whole mouth once daily
dentifrice: twice daily brush thoroughly for 2 minutes
DRUG0.07% Cetylpyridinium chloride
mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Löe-Silness Gingivitis Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational Age (Weeks) | At delivery | log\[42.9-gestational age\] |
Other
| Measure | Time frame |
|---|---|
| Neonate Birth Weight (Grams) | At delivery |
| Preterm Birth (Gestational Age < 37 Weeks) | At delivery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Regular Oral Hygiene toothpaste, toothbrush and dental floss
0.243% sodium fluoride: dentifrice: brush thoroughly twice daily
toothbrush: brush thoroughly twice daily
dental floss: floss the whole mouth once daily | 373 |
| Advanced Oral Hygiene Plus Counseling toothpaste, toothbrush, mouth rinse and dental floss plus specialized education
0.454% stannous fluoride: dentifrice: twice daily brush thoroughly for 2 minutes
toothbrush: twice daily brush thoroughly for 2 minutes
0.07% Cetylpyridinium chloride: mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
dental floss: floss the whole mouth once daily | 373 |
| Total | 746 |
Baseline characteristics
| Characteristic | Advanced Oral Hygiene Plus Counseling | Regular Oral Hygiene | Total |
|---|---|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 6.01 | 27.6 years STANDARD_DEVIATION 5.89 | 27.46 years STANDARD_DEVIATION 5.945 |
| Race/Ethnicity, Customized American Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian Indian | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian Oriential | 15 Participants | 8 Participants | 23 Participants |
| Race/Ethnicity, Customized Black | 262 Participants | 260 Participants | 522 Participants |
| Race/Ethnicity, Customized Caucasian | 77 Participants | 76 Participants | 153 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 13 Participants | 23 Participants |
| Race/Ethnicity, Customized Multi-racial | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Female | 373 Participants | 373 Participants | 746 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 373 | 0 / 373 |
| other Total, other adverse events | 353 / 373 | 329 / 373 |
| serious Total, serious adverse events | 79 / 373 | 75 / 373 |
Outcome results
Primary
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
Population: Numbers indicate participants that were evaluable at 3 months.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Regular Oral Hygiene | Change From Baseline in Löe-Silness Gingivitis Index | 0.141 score on a scale | Standard Error 0.0046 |
| Advanced Oral Hygiene Plus Counseling | Change From Baseline in Löe-Silness Gingivitis Index | 0.154 score on a scale | Standard Error 0.0046 |
Primary
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
Population: Numbers indicate the participants that were evaluable at 2 months.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Regular Oral Hygiene | Change From Baseline in Löe-Silness Gingivitis Index | 0.124 score on a scale | Standard Error 0.0044 |
| Advanced Oral Hygiene Plus Counseling | Change From Baseline in Löe-Silness Gingivitis Index | 0.137 score on a scale | Standard Error 0.0045 |
Primary
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
Population: Numbers indicate the participants that were evaluable at 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Regular Oral Hygiene | Change From Baseline in Löe-Silness Gingivitis Index | 0.112 score on a scale | Standard Error 0.0045 |
| Advanced Oral Hygiene Plus Counseling | Change From Baseline in Löe-Silness Gingivitis Index | 0.125 score on a scale | Standard Error 0.0045 |
Secondary
Gestational Age (Weeks)
log\[42.9-gestational age\]
Time frame: At delivery
Population: This data includes the number of subjects who had evaluable data for the obstetric measure (Gestational Age) was 613. Possible reasons for data being declared as non-evaluable includes: being dropped from the study, failing to have enough product for the duration of pregnancy, missing multiple visits, or failing other protocol criteria.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Regular Oral Hygiene | Gestational Age (Weeks) | 1.3988 log weeks | Standard Error 0.03394 |
| Advanced Oral Hygiene Plus Counseling | Gestational Age (Weeks) | 1.3271 log weeks | Standard Error 0.03403 |
Other Pre-specified
Neonate Birth Weight (Grams)
Time frame: At delivery
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Regular Oral Hygiene | Neonate Birth Weight (Grams) | 3095.97 grams | Standard Error 46.588 |
| Advanced Oral Hygiene Plus Counseling | Neonate Birth Weight (Grams) | 3167.80 grams | Standard Error 45.955 |
Other Pre-specified
Preterm Birth (Gestational Age < 37 Weeks)
Time frame: At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Regular Oral Hygiene | Preterm Birth (Gestational Age < 37 Weeks) | 32 Participants |
| Advanced Oral Hygiene Plus Counseling | Preterm Birth (Gestational Age < 37 Weeks) | 21 Participants |