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

Primary Purpose

Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lubricity
Sponsored by
You First Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HA formulation Oral Spray

    Placebo Oral Spray

    Arm Description

    The Study Examiner and staff will screen for subjects that meet the enrollment criteria. Subjects will be randomly assigned to one of two treatment groups. Oral soft and hard tissue examinations will be conducted at each visit. Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of Experimental mouth spray. They will then be given their assigned product to use twice daily for one week

    The Study Examiner and staff will screen for subjects that meet the enrollment criteria. Subjects will be randomly assigned to one of two treatment groups. Oral soft and hard tissue examinations will be conducted at each visit. Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of placebo mouth spray. They will then be given their assigned product to use twice daily for one week

    Outcomes

    Primary Outcome Measures

    Relief from dry mouth using VAS scoring
    At end of each treatment week they will be asked to answer the following VAS question How well did this product make your mouth feel moist? At end of each treatment week they will be asked to answer the following VAS question At the end of the study they will be asked: How would you rate the second mouthspray compared to the first Study mouthspray in terms of your mouth feeling moist?

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2021
    Last Updated
    January 20, 2021
    Sponsor
    You First Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04719091
    Brief Title
    CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
    Official Title
    CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    February 1, 2016 (Actual)
    Study Completion Date
    February 29, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    You First Services

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This cross-over group, double-blind, randomized, single center, study will enroll 26 subjects to target at least 24 subjects completing the study.Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of mouth spray. They will then be given their assigned product to use twice daily for one week. Subjects will maintain a daily diary of their use of the mouth spray and any oral effects they experience, and will answer all diary questions. Compliance will be assessed by subject diary and measurement of remaining test mouth spray in bottle when unused portion is returned to the clinic. Subjects will also receive 2 questionnaires to complete during the office visit at the end of each 7-day study period. After a 1 week washout, subjects will return to the office to begin the second period of the study, using the same study procedures and be assigned the alternate treatment mouth spray.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Triple(Participant, Care provider, investigator)
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HA formulation Oral Spray
    Arm Type
    Experimental
    Arm Description
    The Study Examiner and staff will screen for subjects that meet the enrollment criteria. Subjects will be randomly assigned to one of two treatment groups. Oral soft and hard tissue examinations will be conducted at each visit. Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of Experimental mouth spray. They will then be given their assigned product to use twice daily for one week
    Arm Title
    Placebo Oral Spray
    Arm Type
    Placebo Comparator
    Arm Description
    The Study Examiner and staff will screen for subjects that meet the enrollment criteria. Subjects will be randomly assigned to one of two treatment groups. Oral soft and hard tissue examinations will be conducted at each visit. Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of placebo mouth spray. They will then be given their assigned product to use twice daily for one week
    Intervention Type
    Device
    Intervention Name(s)
    Lubricity
    Intervention Description
    Oral spray
    Primary Outcome Measure Information:
    Title
    Relief from dry mouth using VAS scoring
    Description
    At end of each treatment week they will be asked to answer the following VAS question How well did this product make your mouth feel moist? At end of each treatment week they will be asked to answer the following VAS question At the end of the study they will be asked: How would you rate the second mouthspray compared to the first Study mouthspray in terms of your mouth feeling moist?
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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

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