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

NCT02788786 | Completed Phase 2

• 1 other identifier: OPP1131701
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Premature Birth of Newborn

Keywords

chlorhexidine; cetylpyridinium chloride; gingival crevicular fluid

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

chlorhexidine

EXPERIMENTAL

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

Drug: Chlorhexidine

cetylpyridinium chloride

EXPERIMENTAL

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

Drug: Cetylpyridinium chloride

Salt and Water

ACTIVE COMPARATOR

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

Drug: Salt and Water

No oral rinse

NO INTERVENTION

No rinse provided in this group

Interventions

Chlorhexidine DRUG

non-alcoholic chlorhexidine gluconate antiseptic mouth rinse

Also known as: chlorhexidine oral rinse

chlorhexidine

Cetylpyridinium chloride DRUG

non-alcoholic cetylpyridinium chloride antiseptic mouth rinse

cetylpyridinium chloride

Salt and Water DRUG

salt and water mix oral rinse

Salt and Water

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Already previously enrolled
• Not Pregnant

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Nepal Nutrition Intervention Project

Hariaun, Sarlahi District, Nepal

Location

Related Publications (2)

• 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.

  PMID: 30611255 DERIVED

• 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.

  PMID: 29859084 DERIVED

MeSH Terms

Conditions

Periodontitis; Premature Birth

Interventions

Chlorhexidine; Cetylpyridinium; Salts; Water

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Luke C Mullany, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 2, 2016
• Study Start: June 27, 2016
• Primary Completion: November 15, 2016
• Study Completion: November 15, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)