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

Primary Purpose

Periodontitis, Premature Birth of Newborn

Status
Completed
Phase
Phase 2
Locations
Nepal
Study Type
Interventional
Intervention
Chlorhexidine
Cetylpyridinium chloride
Salt and Water
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring chlorhexidine, cetylpyridinium chloride, gingival crevicular fluid

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Already previously enrolled
  • Not Pregnant

Sites / Locations

  • Nepal Nutrition Intervention Project

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

chlorhexidine

cetylpyridinium chloride

Salt and Water

No oral rinse

Arm Description

0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks

non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks

Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks

No rinse provided in this group

Outcomes

Primary Outcome Measures

Acceptability
Do women accept the use of their assigned oral rinse?
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2016
Last Updated
February 20, 2017
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02788786
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Premature Birth of Newborn
Keywords
chlorhexidine, cetylpyridinium chloride, gingival crevicular fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chlorhexidine
Arm Type
Experimental
Arm Description
0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks
Arm Title
cetylpyridinium chloride
Arm Type
Experimental
Arm Description
non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks
Arm Title
Salt and Water
Arm Type
Active Comparator
Arm Description
Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks
Arm Title
No oral rinse
Arm Type
No Intervention
Arm Description
No rinse provided in this group
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
chlorhexidine oral rinse
Intervention Description
non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
Intervention Type
Drug
Intervention Name(s)
Cetylpyridinium chloride
Intervention Description
non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
Intervention Type
Drug
Intervention Name(s)
Salt and Water
Intervention Description
salt and water mix oral rinse
Primary Outcome Measure Information:
Title
Acceptability
Description
Do women accept the use of their assigned oral rinse?
Time Frame
12 weeks
Title
Inflammatory markers in gingival crevicular fluid (IL-1β, IL-6, IL-10, TNF-α, PGE2, and GM-CSF)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant <26 weeks gestation at enrollment Enrolled in the broader cohort study Exclusion Criteria: Already previously enrolled Not Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke C Mullany, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepal Nutrition Intervention Project
City
Hariaun
State/Province
Sarlahi District
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30611255
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.
Results Reference
derived
PubMed Identifier
29859084
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.
Results Reference
derived

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

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