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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. Within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from a subset of the area currently engaged in the larger cohort study, to simplify logistics. The pilot trial will have four arms (three oral rinse arms, and one control group).
To select and enroll these 175 participants, data collectors will use the information they collected during an oral health clinical examination conducted at the time of enrollment into the broader cohort study; this information will be used to classify women by signs of periodontitis.
Those selected through this above process will be read an additional consent form; those agreeing to participate will be provided with a supply of their assigned rinse (and instructions on its use and handling/storage), or no rinse. Those in the three rinse groups will be asked to use the provided rinse twice per day after brushing and to save the empty bottles for collection by the health care worker. At the end of this first visit, women will additionally provide a venous blood sample to measure systemic inflammation markers and fluoride.
Women receiving the rinse will be visited by study workers periodically to provide more oral rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks to undergo a second oral health clinical examination and provide a second set of gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the oral rinses as compared to the normal physiological changes in gingival inflammation and biofilm composition during the course of pregnancy.
At this final visit, the women in the three rinse arms will also answer a short questionnaire to gather feedback on acceptability and adherence to the oral rinse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chlorhexidine | Experimental | 0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks |
|
| cetylpyridinium chloride | Experimental | non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks |
|
| Salt and Water | Active Comparator | Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks |
|
| No oral rinse | No Intervention | No rinse provided in this group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | non-alcoholic chlorhexidine gluconate antiseptic mouth rinse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Do women accept the use of their assigned oral rinse? | 12 weeks |
| Inflammatory markers in gingival crevicular fluid (IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF) | Do the oral rinses (or no rinse) have differing impacts on inflammatory markers in gingival crevicular fluid. Specifically, IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF will be measured (pg/ml) using validated multiplex immunoassays. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke C Mullany, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepal Nutrition Intervention Project | Hariaun | Sarlahi District | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30611255 | Derived | Erchick DJ, Rai B, Agrawal NK, Khatry SK, Katz J, LeClerq SC, Reynolds MA, Mullany LC. Oral hygiene, prevalence of gingivitis, and associated risk factors among pregnant women in Sarlahi District, Nepal. BMC Oral Health. 2019 Jan 5;19(1):2. doi: 10.1186/s12903-018-0681-5. | |
| 29859084 | Derived | Lubon AJ, Erchick DJ, Khatry SK, LeClerq SC, Agrawal NK, Reynolds MA, Katz J, Mullany LC. Oral health knowledge, behavior, and care seeking among pregnant and recently-delivered women in rural Nepal: a qualitative study. BMC Oral Health. 2018 Jun 1;18(1):97. doi: 10.1186/s12903-018-0564-9. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D002594 | Cetylpyridinium |
| D012492 | Salts |
| D014867 | Water |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011726 |
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| Cetylpyridinium chloride | Drug | non-alcoholic cetylpyridinium chloride antiseptic mouth rinse |
|
| Salt and Water | Drug | salt and water mix oral rinse |
|
| D007744 |
| Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007287 | Inorganic Chemicals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |