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, a gentle whitening mouthwash, compared with 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 each subject to pool saliva in the floor of the mouth for five minutes before expectorating it into a sterile collection cup. During the study leg involving the test and control agents, subjects rinsed with the assigned oral rinse. Saliva samples were collected twice, at 10 and 40 minutes. During the “no test agent” leg, subjects rinsed with water instead. These measures may also provide useful context when comparing leading whitening rinses and their potential effects on oral health. Additionally, subjects completed a standardized self-evaluation questionnaire for dry mouth and dentinal sensitivity at each visit.