Adherence to and acceptability of three alcohol-free, antiseptic oral rinses: A community-based pilot randomized controlled trial among pregnant women in rural Nepal

Objectives: Antiseptic oral rinses have been evaluated as interventions to reduce the risk of adverse pregnancy outcomes associated with periodontal disease in pregnant women. Oral rinse use is not common in Nepal or other countries in South Asia, where the prevalence of adverse pregnancy outcomes is high. Understanding whether pregnant women in rural communities in this region would incorporate rinse use into their daily teeth cleaning routine is an important prerequisite to future research on this topic in South Asia. Methods: We conducted a community-based pilot randomized controlled trial of three alcohol-free, antiseptic oral rinses among pregnant women <22 weeks pregnant in rural Nepal with the aim of assessing rinse acceptability, adherence, and effect on clinical periodontal measures. At baseline, participants underwent a clinical periodontal examination, and then were classified as healthy or having at least mild gingivitis (≥1 site with probing depth (PD) 3 mm and bleeding on probing (BOP) or ≥4 mm (PD)). Participants were stratified by periodontal status and randomized within each exposure category to chlorhexidine (CHX) (0.12%), cetylpyridinium chloride (CPC) (0.05%), salt and water (NaCl), or control (no rinse). Rinse participants were followed weekly for 12 weeks, and all participants underwent a second periodontal examination and answered a questionnaire. Results: Pregnant women in the rural Terai region of Nepal showed high adherence to (mean weekly rinse use: 185 mL (standard deviation: 66 mL)) a recommended 210 mL and acceptability of all three rinses. Participants reported greater frequency of tooth brushing with toothpaste and improvements in other recommended oral hygiene behaviours. CHX significantly reduced rates of gingivitis (defined as a participant with BOP ≥ 10% of sites) and the extent of BOP (gingivitis at the end of follow-up for CHX vs control: RR 0.37, 95% CI: 0.16, 0.84). CPC and NaCl rinse groups had rates of gingivitis and extent of BOP similar to the control group (gingivitis at the end of follow-up for CPC: RR 0.81, 95% CI: 0.47, 1.38; NaCl: RR 0.92, 95% CI: 0.55, 1.56). Conclusions: Adherence to and acceptability of three alcohol-free, antiseptic oral rinses were high among pregnant women in rural Nepal. Among participants with mild gingivitis at baseline, CHX rinse was most effective at reducing signs of disease compared to the control group. Oral rinse should be considered as a supplement to current oral self-care routines for pregnant women in settings where rinse use is uncommon and access to oral health services is limited.