Dry Mouth, Xerostomia.Hyaluronic Acid, XylitolNCT04719091
CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
A study testing Lubricity in people with Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol, run by You First Services.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol
- What is being tested?
- Lubricity
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
- Being tested
- Lubricity
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubricityDevice
Oral spray
| Study group | Role | What they receive |
|---|---|---|
| HA formulation Oral Spray | Experimental | 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 Receives: Device: Lubricity |
| Placebo Oral Spray | Placebo comparator | 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 Receives: Device: Lubricity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start2 Jan 2016
- Primary completion1 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Mouth, Xerostomia.Hyaluronic Acid, XylitolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- You First Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719091
- Sponsor's protocol ID
- LUX-101-15
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
- ClinicalTrials.gov ID
- NCT04719091
- Acronym / sponsor ID
- LUX-101-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- You First ServicesIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA formulation Oral Spray | Experimental | Device: LubricityThe 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 |
| Placebo Oral Spray | Placebo comparator | Device: LubricityThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LubricityOral spray | Device | HA formulation Oral Spray, Placebo Oral Spray |
Primary outcome
Relief from dry mouth using VAS scoring
Time frame: 3 weeks
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lubricity in people with Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol, run by You First Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief from dry mouth using VAS scoring (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.