Trial Outcomes & Findings for Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM) (NCT NCT01549587)
NCT ID: NCT01549587
Last Updated: 2023-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
746 participants
Primary outcome timeframe
3 months
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
373
|
373
|
|
Overall Study
COMPLETED
|
334
|
336
|
|
Overall Study
NOT COMPLETED
|
39
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)
Baseline characteristics by cohort
| Measure |
Regular Oral Hygiene
n=373 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=373 Participants
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
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.89 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 6.01 • n=7 Participants
|
27.46 years
STANDARD_DEVIATION 5.945 • n=5 Participants
|
|
Sex: Female, Male
Female
|
373 Participants
n=5 Participants
|
373 Participants
n=7 Participants
|
746 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Oriential
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
260 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Numbers indicate participants that were evaluable at 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.
Outcome measures
| Measure |
Regular Oral Hygiene
n=267 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=265 Participants
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
|
|---|---|---|
|
Change From Baseline in Löe-Silness Gingivitis Index
|
0.141 score on a scale
Standard Error 0.0046
|
0.154 score on a scale
Standard Error 0.0046
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Numbers indicate the participants that were evaluable at 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.
Outcome measures
| Measure |
Regular Oral Hygiene
n=278 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=270 Participants
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
|
|---|---|---|
|
Change From Baseline in Löe-Silness Gingivitis Index
|
0.124 score on a scale
Standard Error 0.0044
|
0.137 score on a scale
Standard Error 0.0045
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Numbers indicate the participants that were evaluable at 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.
Outcome measures
| Measure |
Regular Oral Hygiene
n=275 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=273 Participants
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
|
|---|---|---|
|
Change From Baseline in Löe-Silness Gingivitis Index
|
0.112 score on a scale
Standard Error 0.0045
|
0.125 score on a scale
Standard Error 0.0045
|
SECONDARY outcome
Timeframe: At deliveryPopulation: 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.
log\[42.9-gestational age\]
Outcome measures
| Measure |
Regular Oral Hygiene
n=311 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=302 Participants
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
|
|---|---|---|
|
Gestational Age (Weeks)
|
1.3988 log weeks
Standard Error 0.03394
|
1.3271 log weeks
Standard Error 0.03403
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At deliveryOutcome measures
| Measure |
Regular Oral Hygiene
n=311 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=301 Participants
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
|
|---|---|---|
|
Neonate Birth Weight (Grams)
|
3095.97 grams
Standard Error 46.588
|
3167.80 grams
Standard Error 45.955
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At deliveryOutcome measures
| Measure |
Regular Oral Hygiene
n=311 Participants
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
|
Advanced Oral Hygiene Plus Counseling
n=302 Participants
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
|
|---|---|---|
|
Preterm Birth (Gestational Age < 37 Weeks)
|
32 Participants
|
21 Participants
|
Adverse Events
Regular Oral Hygiene
Serious events: 79 serious events
Other events: 353 other events
Deaths: 0 deaths
Advanced Oral Hygiene Plus Counseling
Serious events: 75 serious events
Other events: 329 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regular Oral Hygiene
n=373 participants at risk
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
|
Advanced Oral Hygiene Plus Counseling
n=373 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Cardiac disorders
CARDIOMEGALY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Cardiac disorders
FOETAL HEART RATE DECELERATION
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Cardiac disorders
PULMONARY VALVE STENOSIS
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
CHROMOSOMAL DELETION
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
FALLOT'S TETRALOGY
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
POLYDACTYLY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERY STENOSIS CONGENITAL
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
RENAL APLASIA
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
SICKLE CELL ANAEMIA WITH CRISIS
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
TRANSPOSITION OF THE GREAT VESSELS
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
TRISOMY 21
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Immune system disorders
ALLOIMMUNISATION
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Immune system disorders
RHESUS INCOMPATIBILITY
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
APPENDICITIS
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
CHORIOAMNIONITIS
|
3.8%
14/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
2.7%
10/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
PNEUMONIA
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Injury, poisoning and procedural complications
ABDOMINAL INJURY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Investigations
FOETAL HEART RATE ABNORMAL
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Musculoskeletal and connective tissue disorders
FINGER DEFORMITY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Musculoskeletal and connective tissue disorders
NOSE DEFORMITY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Nervous system disorders
CEREBRAL VENTRICLE DILATATION
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Nervous system disorders
HEADACHE
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION THREATENED
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
CERVICAL INCOMPETENCE
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DISTRESS SYNDROME
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL GROWTH RESTRICTION
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
1.9%
7/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL HYPERTENSION
|
2.1%
8/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
1.9%
7/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
HAEMORRHAGE IN PREGNANCY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
HELLP SYNDROME
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
IMMINENT ABORTION
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
OLIGOHYDRAMNIOS
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PLACENTA PRAEVIA HAEMORRHAGE
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
5.6%
21/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
3.2%
12/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE DELIVERY
|
7.2%
27/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
4.0%
15/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
1.6%
6/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
1.9%
7/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE RUPTURE OF MEMBRANES
|
2.4%
9/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
1.9%
7/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE SEPARATION OF PLACENTA
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
STILLBIRTH
|
1.1%
4/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
UTERINE CONTRACTIONS DURING PREGNANCY
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Renal and urinary disorders
KETONURIA
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Renal and urinary disorders
PYELOCALIECTASIS
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.54%
2/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
1.1%
4/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE CHEST SYNDROME
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.27%
1/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Vascular disorders
HYPERTENSION
|
0.80%
3/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
0.00%
0/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
Other adverse events
| Measure |
Regular Oral Hygiene
n=373 participants at risk
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
|
Advanced Oral Hygiene Plus Counseling
n=373 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.4%
35/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
11.0%
41/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
NAUSEA
|
4.8%
18/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
5.1%
19/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Gastrointestinal disorders
VOMITING
|
3.8%
14/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
5.1%
19/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
CHORIOAMNIONITIS
|
6.4%
24/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
5.9%
22/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.2%
27/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
4.8%
18/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
5.6%
21/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
6.4%
24/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Investigations
STREPTOCOCCUS TEST POSITIVE
|
23.6%
88/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
25.2%
94/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Nervous system disorders
HEADACHE
|
5.1%
19/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
3.5%
13/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
6.7%
25/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
4.6%
17/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL HYPERTENSION
|
5.1%
19/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
5.1%
19/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
6.2%
23/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
4.0%
15/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE DELIVERY
|
10.7%
40/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
7.5%
28/373 • Participants were enrolled 8-24 weeks into pregnancy until delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Joint agreement with PIs.
- Publication restrictions are in place
Restriction type: OTHER