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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Oral Hygiene | Active Comparator | toothpaste, toothbrush and dental floss |
|
| Advanced Oral Hygiene plus counseling | Experimental | toothpaste, toothbrush, mouth rinse and dental floss plus specialized education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.243% sodium fluoride | Drug | dentifrice: brush thoroughly twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| 3 months |
| Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| 2 months |
| Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age (Weeks) | log[42.9-gestational age] | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Neonate Birth Weight (Grams) | At delivery | |
| Preterm Birth (Gestational Age < 37 Weeks) | At delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Jeffcoat, DMD | School of Dentistry University of Pennsylvania | Principal Investigator |
| Michael Reddy, DMD, DMSc | School of Dentistry University of Alabama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Women's Reproductive Health | Birmingham | Alabama | 35294-0024 | United States | ||
| Penn OB/Gyn and Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37127210 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Advanced Oral Hygiene Plus Counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| Numbers indicate participants that were evaluable at 3 months. | Posted | Least Squares Mean | Standard Error | score on a scale | 3 months |
|
Participants were enrolled 8-24 weeks into pregnancy until delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter & Gamble | 5136225362 | combs.cs@pg.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2013 | Apr 19, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2015 | Apr 19, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D012969 | Sodium Fluoride |
| D003742 | Dental Devices, Home Care |
| D014002 | Tin Fluorides |
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| toothbrush | Device | brush thoroughly twice daily |
|
|
| dental floss | Device | floss the whole mouth once daily |
|
|
| 0.454% stannous fluoride | Drug | dentifrice: twice daily brush thoroughly for 2 minutes |
|
|
| toothbrush | Device | twice daily brush thoroughly for 2 minutes |
|
|
| 0.07% Cetylpyridinium chloride | Drug | mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily |
|
|
| dental floss | Device | floss the whole mouth once daily |
|
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | 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 |
|
|
| Primary | Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| Numbers indicate the participants that were evaluable at 2 months. | Posted | Least Squares Mean | Standard Error | score on a scale | 2 months |
|
|
|
| Primary | Change From Baseline in Löe-Silness Gingivitis Index | Score Criteria 0 Normal gingiva.
| Numbers indicate the participants that were evaluable at 1 month | Posted | Least Squares Mean | Standard Error | score on a scale | 1 month |
|
|
|
| Secondary | Gestational Age (Weeks) | log[42.9-gestational age] | 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. | Posted | Least Squares Mean | Standard Error | log weeks | At delivery |
|
|
|
| Other Pre-specified | Neonate Birth Weight (Grams) | Posted | Least Squares Mean | Standard Error | grams | At delivery |
|
|
|
| Other Pre-specified | Preterm Birth (Gestational Age < 37 Weeks) | Posted | Count of Participants | Participants | At delivery |
|
|
|
| 0 |
| 373 |
| 79 |
| 373 |
| 353 |
| 373 |
| EG001 | 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 | 0 | 373 | 75 | 373 | 329 | 373 |
| CARDIOMEGALY | Cardiac disorders | Systematic Assessment |
|
| FOETAL HEART RATE DECELERATION | Cardiac disorders | Systematic Assessment |
|
| PULMONARY VALVE STENOSIS | Cardiac disorders | Systematic Assessment |
|
| CHROMOSOMAL DELETION | Congenital, familial and genetic disorders | Systematic Assessment |
|
| FALLOT'S TETRALOGY | Congenital, familial and genetic disorders | Systematic Assessment |
|
| POLYDACTYLY | Congenital, familial and genetic disorders | Systematic Assessment |
|
| PULMONARY ARTERY STENOSIS CONGENITAL | Congenital, familial and genetic disorders | Systematic Assessment |
|
| RENAL APLASIA | Congenital, familial and genetic disorders | Systematic Assessment |
|
| SICKLE CELL ANAEMIA WITH CRISIS | Congenital, familial and genetic disorders | Systematic Assessment |
|
| TRANSPOSITION OF THE GREAT VESSELS | Congenital, familial and genetic disorders | Systematic Assessment |
|
| TRISOMY 21 | Congenital, familial and genetic disorders | Systematic Assessment |
|
| VENTRICULAR SEPTAL DEFECT | Congenital, familial and genetic disorders | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | Systematic Assessment |
|
| ALLOIMMUNISATION | Immune system disorders | Systematic Assessment |
|
| RHESUS INCOMPATIBILITY | Immune system disorders | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | Systematic Assessment |
|
| CHORIOAMNIONITIS | Infections and infestations | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | Systematic Assessment |
|
| MENINGITIS VIRAL | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | Systematic Assessment |
|
| ABDOMINAL INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
|
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | Systematic Assessment |
|
| CARDIAC MURMUR | Investigations | Systematic Assessment |
|
| FOETAL HEART RATE ABNORMAL | Investigations | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| FINGER DEFORMITY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NOSE DEFORMITY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CEREBRAL VENTRICLE DILATATION | Nervous system disorders | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| ABORTION MISSED | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| ABORTION THREATENED | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| CERVICAL INCOMPETENCE | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| FOETAL DISTRESS SYNDROME | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| FOETAL GROWTH RESTRICTION | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| GESTATIONAL DIABETES | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| GESTATIONAL HYPERTENSION | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| HAEMORRHAGE IN PREGNANCY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| HELLP SYNDROME | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| IMMINENT ABORTION | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| OLIGOHYDRAMNIOS | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PLACENTA PRAEVIA HAEMORRHAGE | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PRE-ECLAMPSIA | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PREMATURE DELIVERY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PREMATURE LABOUR | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PREMATURE RUPTURE OF MEMBRANES | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PREMATURE SEPARATION OF PLACENTA | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| STILLBIRTH | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| UTERINE CONTRACTIONS DURING PREGNANCY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| KETONURIA | Renal and urinary disorders | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | Systematic Assessment |
|
| PYELOCALIECTASIS | Renal and urinary disorders | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | Systematic Assessment |
|
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | Systematic Assessment |
|
| ACUTE CHEST SYNDROME | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
| CHORIOAMNIONITIS | Infections and infestations | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | Systematic Assessment |
|
| STREPTOCOCCUS TEST POSITIVE | Investigations | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | Systematic Assessment |
|
| GESTATIONAL DIABETES | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| GESTATIONAL HYPERTENSION | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PRE-ECLAMPSIA | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| PREMATURE DELIVERY | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
Joint agreement with PIs.
| D009057 |
| Stomatognathic Diseases |
| D017670 |
| Sodium Compounds |
| D002327 | Cariostatic Agents |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D004864 | Equipment and Supplies |
| D017971 | Tin Compounds |
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |