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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788786
• Other study ID #: OPP1131701
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2016
• Last updated: February 20, 2017
• Start date: June 27, 2016
• Est. completion date: November 15, 2016

Study information

• Verified date: January 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Pregnant

• <26 weeks gestation at enrollment

• Enrolled in the broader cohort study

Exclusion Criteria:

• Already previously enrolled

• Not Pregnant

Related Conditions & MeSH terms

• Periodontitis
• Premature Birth
• Premature Birth of Newborn

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Nepal	Nepal Nutrition Intervention Project	Hariaun	Sarlahi District

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Do women accept the use of their assigned oral rinse?	12 weeks
Primary	Inflammatory markers in gingival crevicular fluid (IL-1ß, IL-6, IL-10, TNF-a, PGE2, and GM-CSF)	Do the oral rinses (or no rinse) have differing impacts on inflammatory markers in gingival crevicular fluid. Specifically, IL-1ß, IL-6, IL-10, TNF-a, PGE2, and GM-CSF will be measured (pg/ml) using validated multiplex immunoassays.	12 weeks