Mutans StreptococciNCT01823445
Xylitol Disk Use in Adults With Dry Mouth
A study testing Xylitol disk in people with Mutans Streptococci and Xerostomia, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mutans Streptococci, Xerostomia
- What is being tested?
- Xylitol disk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2013
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 21 years old or older
- Daily use of at least 2 prescription medications known to cause dry mouth
- Current report of dry mouth
Who cannot join
- Antibiotic use in the last month
- Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
- Change in medication or dose within the last month
- Use of mouthwash within the last week
- Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
- History of gastrointestinal disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, School of Dentistry, Regional Clinical Dental Research Center
Seattle, Washington, 98195
About this study
Official title: XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.
Read the detailed description
Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci.
The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.
- Conditions
- Mutans Streptococci, Xerostomia
- Being tested
- Xylitol disk
- Keywords
- Xylitol, Dental caries
- Medical subject headings
- Xerostomia, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol diskOther
Also called XyliMelts
| Study group | Role | What they receive |
|---|---|---|
| Xylitol disk | Experimental | Daily use of 8 disks containing 0.5 grams xylitol each for two weeks. The disks adhere to gum tissue with a food grade adhesive backing and slowly dissolve. The disks are applied one on each side of the mouth in the morning after breakfast, again at midday, and four are applied, two on each side, at bedtime. Receives: Other: Xylitol disk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutans streptococci levels
Change in mutans streptococci levels from Baseline to one week.
Measured: One week
Mutans streptococci levels
Change in mutans streptococci levels from Baseline to two weeks.
Measured: Two weeks
Secondary outcomes (2)
GRIX measure of xerostomia
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to one week.
Measured: One week
GRIX measure of xerostomia
Change in Groningen Radiotherapy-Induced Xerostomia (GRIX) quality of life questionnaire assessing xerostomia symptoms from Baseline to two weeks.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mutans StreptococciStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Milgrom, University of Washington
- Investigators
- Peter Milgrom, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823445
- Sponsor's protocol ID
- XM2013
- Status last verified
- Dec 2013
- First submitted
- 27 Mar 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XyliMelts Ability to Reduce Mutans Streptococci in Adults With the Perception of Dry Mouth
- ClinicalTrials.gov ID
- NCT01823445
- Acronym / sponsor ID
- XM2013
- Conditions
- Mutans Streptococci, Xerostomia
- Keywords
- Xylitol, Dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- 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.
The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.
Detailed description
Xylitol,an FDA approved sugar substitute, has been shown to reduce tooth decay. Patients who experience dry mouth may be more susceptible to dental decay because they lack the protection provided by an adequate flow of saliva. These patients are likely to have high levels of the decay causing bacteria, mutans streptococci.
The purpose of this research is to test the ability of a novel xylitol delivery vehicle to reduce mutans streptococci in patients with dry mouth over a two week period. The delivery vehicle is a slowly dissolving xylitol disk (lozenge) that adheres to soft tissues inside the mouth. Participants will place disks on both sides of the mouth three times a day.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xylitol disk | Experimental | Other: Xylitol diskDaily use of 8 disks containing 0.5 grams xylitol each for two weeks. The disks adhere to gum tissue with a food grade adhesive backing and slowly dissolve. The disks are applied one on each side of the mouth in the morning after breakfast, again at midday, and four are applied, two on each side, at bedtime. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 21 years old or older
- Daily use of at least 2 prescription medications known to cause dry mouth
- Current report of dry mouth
Key exclusion criteria (6 listed)
- Antibiotic use in the last month
- Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
- Change in medication or dose within the last month
- Use of mouthwash within the last week
- Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
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 |
|---|---|---|
| Xylitol diskAlso: XyliMelts | Other | Xylitol disk |
Primary outcome
Mutans streptococci levels
Time frame: One week
Change in mutans streptococci levels from Baseline to one week.
Mutans streptococci levels
Time frame: Two weeks
Change in mutans streptococci levels from Baseline to two weeks.
2 secondary outcomes
GRIX measure of xerostomia
Time frame: One week
GRIX measure of xerostomia
Time frame: Two weeks
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 3 Dec 2013.
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.
Peter Milgrom, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol disk in people with Mutans Streptococci and Xerostomia, run by University of Washington at 1 site in United States.
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 3 inclusion and 6 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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Mutans streptococci levels (time frame: One week). The study lists 2 primary outcomes in all. 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 3 Dec 2013.