Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects

NCT ID: NCT03005041

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-10-19

Brief Summary

The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth

Conditions

Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Test Product 1

Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds.

Group Type: EXPERIMENTAL

Biotene mouthwash

Intervention Type: OTHER

Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.

Test Product 2

Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water.

Group Type: OTHER

Bottled mineral water

Intervention Type: OTHER

Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.

Interventions

Biotene mouthwash

Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.

Intervention Type: OTHER

Bottled mineral water

Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Aged 18 - 84 years inclusive
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
• Participant reports having a feeling of a dry mouth according to the Dry Mouth Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1). Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the Screening Visit (Visit 1).
• Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the Screening Visit (Visit 1).
• Understands and is willing, able and likely to comply with all study procedures and restrictions

Exclusion Criteria

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or have a positive urine pregnancy test at the Screening Visit
• Women who are breast-feeding
• Participant is currently undergoing radiotherapy and/or chemotherapy treatment
• Any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. Alzheimer's Disease
• Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
• Evidence of gross intra-oral neglect or need for extensive dental therapy
• Denture wearer (complete dentures)
• Participant not on stable doses of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
• Previous participation in this study
• Recent history (within the last 1 year) of alcohol or other substance abuse
• An employee of the sponsor or the clinical study team or members of their immediate family. Students and employees of the Tufts University School of Dental Medicine not associated with the clinical trials team are eligible to participate. Students and employees will not be specifically targeted for enrollment
• Non-English speaking Participants will not be enrolled in the study. Participants must be able to read and write in English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

205067

Identifier Type: -

Identifier Source: org_study_id