Lumineux vs. Biotene Rinse Study
Our goal is to identify in patients with xerostomia the effects of a novel test agent (Oral Essentials Hydrating Formula mouthwash, Beverly Hills, CA) vs a control agent (Biotene Dry Mouth Oral Rinse) and no treatment on dry mouth, oral biofilm, salivary pH and buffering capacity, gingival health, and tooth sensitivity
Ten subjects with xerostomia (please see inclusion/exclusion criteria below) participated in this study. The study had 3 legs, whereby in two legs subjects used a test or control xerostomia intervention; in the third leg they used no intervention for xerostomia. Subjects were randomized with regard to sequence of the 3 legs of the study. Subjects also underwent plaque staining and standardized photography at baseline and at the end of each study leg. Digital image analysis was performed to identify plaque age (color-based) and surface coverage in the oral cavity. ORAL ESSENTIALS XEROSTOMIA CLINICAL TEST
Plaque Index (PI), Gingival Index (GI) and Sulcus Bleeding Index (mSBI) were recorded at baseline and at the end of each study leg to provide a quantitative measure of gingival health. Salivary volume, pH and buffering capacity were determined by asking the subject to pool saliva in the floor of their mouth for a 5 minute duration, then expectorate the saliva into a sterile collecting cup. During the leg incorporating test and control agent use, subjects rinsed with the test/control agent. Saliva pooling/expectoration were collected twice, at t=10 and t=40 mins. During the “no test agent” leg, subjects rinsed with water instead. Additionally, subjects completed a standardized self-evaluation questionnaire for dry mouth and dentinal sensitivity at each visit.