xerostomia or dry mouth symptoms. xerostomia, drymouth
Conditions
Interventions
mouth spray that contains the biopolymer of chitosan and other compositions.,mouth spray that contains the compositions except the biopolymer of chitosan.
Experimental Other,Placebo Comparator Other
chitosan mouth spray,mouth spray
Sponsors
Research, Innovation and Academic Services Fund, Faculty of Dentistry Khon Kaen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals with xerostomia having a xerostomia inventory score greater than 11 points 2. Individuals with physical health status according to ASA (American Society of Anesthesiologists) class I and class II, including those with well-controlled diabetes mellitus with hemoglobin A1C (HbA1C) level not exceeding 7% or fasting plasma glucose (FPG) level of 80-130 mg/dL, and those with controlled hypertension with blood pressure not exceeding 130/79 mmHg for ages 18-65 years, and not exceeding 139/79 mmHg for ages 65 years and above.
Exclusion criteria
Exclusion criteria: Individuals with a history of radiation therapy (head and neck region) or chemotherapy, Individuals with a history of autoimmune diseases, including Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, and scleroderma, Individuals currently being treated for xerostomia with pilocarpine or cevimeline Individuals with a history of chitosan allergy or seafood allergy Individuals allergic to product ingredients such as preservatives, fragrances, etc. Individuals who regularly consume alcoholic beverages (drinking 2 or more times per month or once or more per week) Individuals with bleeding on probing (BOP) greater than 10% according to the 2017 American Academy of Periodontology (AAP) criteria Individuals with oral lesions caused by infection or inflammation Individuals who have received antibiotics, steroids, or immunosuppressive drugs within the past 3 months Individuals who have received systemic or topical antifungal medications in the oral cavity within the past 1 month Individuals who smoke Individuals who use cannabis or other illicit drugs Individuals who are pregnant or breastfeeding Individuals with cognitive impairment or inability to communicate through listening, speaking, reading, or writing in Thai Individuals who are unwilling or not voluntarily willing to participate in the research until completion and cooperate in following the protocol recommended by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dry mouth at 1 months after intervention xerostomia inventory scores, clinical oral dryness score, unstimulated salivary flow rate, salivary pH, salivary buffering capacity | — |
Secondary
| Measure | Time frame |
|---|---|
| microbial at 1 months after intervention colony count of Streptococcus mutans and Candida species.,Satisfaction and adverse effects at 1 months after intervention Satisfaction and adverse effect questionaire | — |
Countries
Thailand
Contacts
Public ContactWilairat Sarideechaigul
Faculty of Dentistry, Khon Kaen University
Outcome results
None listed