Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal

Study Overview
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Brief Summary
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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). Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with periodontitis Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without periodontitis) Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without periodontitis) Arm 4: No oral rinse (n=50) 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.

Official Title
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Feasibility and Acceptability of Daily Oral Rinse in Pregnant Women and Impact on Oral Inflammatory Biomarkers in Rural Nepal

Conditions
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Periodontitis, Premature Birth of Newborn

Intervention / Treatment
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* Drug: Chlorhexidine
* Drug: Cetylpyridinium chloride
* Drug: Salt and Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant <26 weeks gestation at enrollment Enrolled in the broader cohort study Exclusion Criteria: Already previously enrolled Not Pregnant

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine<br>0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks | Drug: Chlorhexidine<br>* non-alcoholic chlorhexidine gluconate antiseptic mouth rinse<br>* Other names: chlorhexidine oral rinse;|
| Experimental: cetylpyridinium chloride<br>non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks | Drug: Cetylpyridinium chloride<br>* non-alcoholic cetylpyridinium chloride antiseptic mouth rinse<br>|
| Active Comparator: Salt and Water<br>Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks | Drug: Salt and Water<br>* salt and water mix oral rinse<br>|
| No Intervention: No oral rinse<br>No rinse provided in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chlorhexidine, cetylpyridinium chloride, gingival crevicular fluid