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
Conditions: Periodontitis
Premature Birth of Newborn
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.
Interventions:
description: non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
name: Chlorhexidine
other_name: chlorhexidine oral rinse
type: Drug
description: non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
name: Cetylpyridinium chloride
type: Drug
description: salt and water mix oral rinse
name: Salt and Water
type: Drug
Study arms:
design_group_description: 0.12% w/v chlorhexidine oral rinse; 15ml, twice-daily, for 12 weeks
design_group_title: chlorhexidine
design_group_type: Experimental
design_group_description: non-alcoholic cetylpyridinium chloride oral rinse; 15ml, twice-daily, for 12 weeks
design_group_title: cetylpyridinium chloride
design_group_type: Experimental
design_group_description: Salt and water based oral rinse; 15ml, twice-daily, for 12 weeks
design_group_title: Salt and Water
design_group_type: Active Comparator
design_group_description: No rinse provided in this group
design_group_title: No oral rinse
design_group_type: No Intervention
Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: Gates Foundation (United States)
Drug name mappings:
name: 西吡氯铵
lang: CN
name: Cetylpyridinium Chloride Hydrate
lang: EN
name: セチルピリジニウム塩化物水和物
lang: JP
name: 葡萄糖氯己定
lang: CN
name: Chlorhexidine gluconate
lang: EN
name: クロルヘキシジングルコン酸塩
lang: JP