Clinical trial NCT02788786: Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal
Official title: Feasibility and Acceptability of Daily Oral Rinse in Pregnant Women and Impact on Oral Inflammatory Biomarkers in Rural Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontitis
Premature Birth of Newborn
Keywords: chlorhexidine
cetylpyridinium chloride
gingival crevicular fluid
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2016-06-02
Enrollment: 175
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* \<26 weeks gestation at enrollment
* Enrolled in the broader cohort study

Exclusion Criteria:

* Already previously enrolled
* Not Pregnant

Primary outcomes:
measure: Acceptability
timeFrame: 12 weeks
measure: Inflammatory markers in gingival crevicular fluid (IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hariaun
country: Nepal
facility: Nepal Nutrition Intervention Project
state: Sarlahi District
Study officials:
affiliation: Johns Hopkins University
name: Luke C Mullany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.