Participants and eligibility
head and neck radiotherapy, allergy, psychiatric, oropharyngeal lesions, hypersensitivity, lichen planus, chronic mucosal lesions
ALLERGY, HYPERSENSITIVITY, LICHEN PLANUS
Patients were identified in the inpatient wards of Newham University and The Royal London Hospitals (Barts Health NHS Trust, United Kingdom) between April and October 2021, during two peaks of the pandemic and when delta was the prevalent COVID-19 strainMales and females, ≥ 18 years old.COVID-19 positive confirmed via any diagnostic test and/or presented with COVID-19 clinical symptoms at time of consent.The exclusion criteria were:known pre-existing chronic mucosal lesions e.g., lichen planus or other oropharyngeal lesions, reported by patient or recorded in the existing patient’ medical notes;patients intubated or not capable of mouth rinsing or spitting;history of head and neck radiotherapy or chemotherapy;self-reported xerostomia;known allergy or hypersensitivity to chlorhexidine digluconate or any of the mouthwashes constituents;other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or could interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into the trial.inability to comply with study protocol.The judgment of the investigator was based on the patients’ direct care medical team opinion/recommendation. Before approaching potential participants investigators communicated with patients’ direct care medical team to understand if patient was medically stable and if their participation in the study would not worsen their condition, as well as if they were mentally and physically able to consent and comply with the study protocol.Potential participants were then approached and provided with the study Patient Information Sheet (PIS) and received explanation about the study. The eligible patients interested in taking part in the study were then invited to sign an informed consent form. Whenever available, COVID-19 test results were confirmed before the patient entered the study. For those patients presenting COVID-19 clinical symptoms at time of consent, positive test status was confirmed within 2 weeks from the date the patient has been consented into the study.Out of 177 inpatients initially screened, 54 fulfilled the eligibility criteria and were consented for the study. Beyond the initial sample size (n = 40) more participants were recruited into the study, as some of the patients presenting with clinical symptoms at point of consent tested negative for COVID-19 (n = 4) and some of participants initially confirmed as COVID-19 positive by diagnostic test had undetectable SARS-CoV-2 viral RNA in the baseline saliva samples (7; 14.9%). Additionally, after enrolment, 1 participant withdrew consent and 2 were withdrawn from the study by the researcher due to deteriorating medical condition. Characteristics of patients consented but not included (n = 14) in the analysis are presented in the Table In addition, up to 5 COVID-19 negative participants were recruited and provided signed informed consent as volunteers from, Barts and The London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London to set up the saliva profile of COVID-19 negative patients for analysis.