CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA

Launched by YOU FIRST SERVICES · Jan 20, 2021

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Eligibility criteria

• Inclusion Criteria:
• • Have provided written informed consent prior to being entered into the study.
• • Must be at least 18 years of age, male or female.
• • Have at least 12 natural or restored teeth.
• • Have a negative history of radiation therapy to head and neck
• • Have a complaint of xerostomia
• • Have an unstimulated salivary flow rate \<0.25ml/minute which represents 35-50% of normal salivary function
• • Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study.
• • Agree to abstain from the use of any products for xerostomia other than those provided in the study.
• • Agree to comply with the conditions and schedule of the study.
• Exclusion Criteria:
• • Physical limitations or restrictions that might preclude normal tooth brushing.
• • Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.
• • Presence of severe gingivitis with 30 or more sites showing bleeding on probing.
• • Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
• • Chronic disease with concomitant oral manifestations other than xerostomia
• • Conditions requiring antibiotic treatment prior to dental prophylaxis and invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants.
• • History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS).
• • Subjects who are currently undergoing, or require, extensive dental work or orthodontic treatment.
• • Currently using bleaching trays.
• • History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth sprays.
• • Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.