Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal
NCT ID: NCT02788786
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2016-06-27
2016-11-15
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chlorhexidine
0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks
Chlorhexidine
non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
cetylpyridinium chloride
non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks
Cetylpyridinium chloride
non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
Salt and Water
Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks
Salt and Water
salt and water mix oral rinse
No oral rinse
No rinse provided in this group
No interventions assigned to this group
Interventions
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Chlorhexidine
non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
Cetylpyridinium chloride
non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
Salt and Water
salt and water mix oral rinse
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \<26 weeks gestation at enrollment
* Enrolled in the broader cohort study
Exclusion Criteria
* Not Pregnant
15 Years
FEMALE
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Luke C Mullany, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Nepal Nutrition Intervention Project
Hariaun, Sarlahi District, Nepal
Countries
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References
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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.
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.
Other Identifiers
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OPP1131701
Identifier Type: -
Identifier Source: org_study_id
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