Dental CariesPhase 3NCT00393055
Xylitol Adult Caries Trial (X-ACT)
A Phase 3 study testing xylitol and inactive lozenge in people with Dental Caries, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial summary
The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- xylitol and inactive lozenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 709 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Jun 2011
- Phase
- Phase 3
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 25-80
- at least one caries lesion in year prior to enrollment
- at least 12 teeth without crowns
- no allergies to xylitol or aspartame
- anticipate remaining in area for 3 years
Who cannot join
- 10 or more caries lesions in year prior to enrollment
- currently receiving long-term antibiotic therapy
- history of head and neck radiation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111
University of North Carolina School of Dentistry
Chapel Hill, North Carolina, 27599-7450
University of Texas Health Science Center
San Antonio, Texas, 78229-3900
About this study
The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).
Read the detailed description
Dental caries incidence is higher in adults than children. Recent recommendations from both the Centers for Disease Control and an NIH Consensus Development Conference on dental caries call for clinical trials of caries prevention methods in caries-active adults. Little is known about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are at elevated risk for developing caries lesions. This application describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the CDC and Consensus Conference recommendations.
The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. The intervention is the daily use of xylitol lozenges. Participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of three Clinical Centers in Chapel Hill, NC, Birmingham, AL, and San Antonio TX. These Clinical Centers offer diverse populations with substantial proportions of minority populations that enhance the generalizability of the findings. The Study Chair is located at the University of North Carolina-Chapel Hill, and the Data Coordinating Center is at the Kaiser Permanente Center for Health Research in Portland, OR.
This intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their caries-active patients. The potential for adoption of the intervention is an important consideration because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. If effective, the intervention also holds potential as a public health measure.
- Conditions
- Dental Caries
- Being tested
- xylitol, inactive lozenge
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylitolDietary supplement
1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years
inactive lozengeDietary supplement
Also called placebo
1g inactive lozenge, dissolved in mouth. Five/day for three years
| Study group | Role | What they receive |
|---|---|---|
| xylitol lozenge | Experimental | 1g xylitol lozenge. Five/day, dissolved in mouth Receives: Dietary Supplement: xylitol |
| inactive lozenge | Placebo comparator | 1g placebo lozenge. Five/day, dissolved in mouth Receives: Dietary Supplement: inactive lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined root and coronal D2FS (dental caries) increment
Measured: 3 year
Secondary outcomes (3)
combined root and coronal D12FS (dental caries) increment
Measured: three year
separate root and coronal D12FS (dental caries) increments
Measured: 3 years
association of lozenge use with D12FS (dental caries) in control group only
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Jim Bader, DDS, University of North Carolina, Chapel Hill
- Investigators
- James D Bader, DDS MPH, Principal investigator, UNC School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393055
- Sponsor's protocol ID
- NIDCR-18038
- Other IDs
- U01DE018038
- Status last verified
- Sep 2011
- First submitted
- 25 Oct 2006
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown JP, Amaechi BT, Bader JD, Gilbert GH, Makhija SK, Lozano-Pineda J, Leo MC, Chen C, Vollmer WM; X-ACT Trial Collaborative Group. Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults. Community Dent Oral Epidemiol. 2014 Jun;42(3):271-8. doi: 10.1111/cdoe.12082. Epub 2013 Nov 8.
PubMed 24205951Ritter AV, Bader JD, Leo MC, Preisser JS, Shugars DA, Vollmer WM, Amaechi BT, Holland JC. Tooth-surface-specific effects of xylitol: randomized trial results. J Dent Res. 2013 Jun;92(6):512-7. doi: 10.1177/0022034513487211. Epub 2013 Apr 15.
PubMed 23589387Bader JD, Vollmer WM, Shugars DA, Gilbert GH, Amaechi BT, Brown JP, Laws RL, Funkhouser KA, Makhija SK, Ritter AV, Leo MC. Results from the Xylitol for Adult Caries Trial (X-ACT). J Am Dent Assoc. 2013 Jan;144(1):21-30. doi: 10.14219/jada.archive.2013.0010.
PubMed 23283923Bader JD, Shugars DA, Vollmer WM, Gullion CM, Gilbert GH, Amaechi BT, Brown JP. Design of the xylitol for adult caries trial (X-ACT). BMC Oral Health. 2010 Sep 29;10:22. doi: 10.1186/1472-6831-10-22.
PubMed 20920261
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol Adult Caries Trial (X-ACT)
- ClinicalTrials.gov ID
- NCT00393055
- Acronym / sponsor ID
- NIDCR-18038
- Conditions
- Dental Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Oct 2006 (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 the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).
Detailed description
Dental caries incidence is higher in adults than children. Recent recommendations from both the Centers for Disease Control and an NIH Consensus Development Conference on dental caries call for clinical trials of caries prevention methods in caries-active adults. Little is known about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are at elevated risk for developing caries lesions. This application describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the CDC and Consensus Conference recommendations.
The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. The intervention is the daily use of xylitol lozenges. Participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of three Clinical Centers in Chapel Hill, NC, Birmingham, AL, and San Antonio TX. These Clinical Centers offer diverse populations with substantial proportions of minority populations that enhance the generalizability of the findings. The Study Chair is located at the University of North Carolina-Chapel Hill, and the Data Coordinating Center is at the Kaiser Permanente Center for Health Research in Portland, OR.
This intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their caries-active patients. The potential for adoption of the intervention is an important consideration because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. If effective, the intervention also holds potential as a public health measure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xylitol lozenge | Experimental | Dietary Supplement: xylitol1g xylitol lozenge. Five/day, dissolved in mouth |
| inactive lozenge | Placebo comparator | Dietary Supplement: inactive lozenge1g placebo lozenge. Five/day, dissolved in mouth |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 25-80
- at least one caries lesion in year prior to enrollment
- at least 12 teeth without crowns
- no allergies to xylitol or aspartame
- anticipate remaining in area for 3 years
Key exclusion criteria (3 listed)
- 10 or more caries lesions in year prior to enrollment
- currently receiving long-term antibiotic therapy
- history of head and neck radiation
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 |
|---|---|---|
| xylitol1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years | Dietary supplement | xylitol lozenge |
| inactive lozengeAlso: placebo1g inactive lozenge, dissolved in mouth. Five/day for three years | Dietary supplement | inactive lozenge |
Primary outcome
combined root and coronal D2FS (dental caries) increment
Time frame: 3 year
3 secondary outcomes
combined root and coronal D12FS (dental caries) increment
Time frame: three year
separate root and coronal D12FS (dental caries) increments
Time frame: 3 years
association of lozenge use with D12FS (dental caries) in control group only
Time frame: 3 years
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 12 Sep 2011.
- Derived from this study: PubMed 24205951Brown JP, Amaechi BT, Bader JD, Gilbert GH, Makhija SK, Lozano-Pineda J, Leo MC, Chen C, Vollmer WM; X-ACT Trial Collaborative Group. Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults. Community Dent Oral Epidemiol. 2014 Jun;42(3):271-8. doi: 10.1111/cdoe.12082. Epub 2013 Nov 8.
- Derived from this study: PubMed 23589387Ritter AV, Bader JD, Leo MC, Preisser JS, Shugars DA, Vollmer WM, Amaechi BT, Holland JC. Tooth-surface-specific effects of xylitol: randomized trial results. J Dent Res. 2013 Jun;92(6):512-7. doi: 10.1177/0022034513487211. Epub 2013 Apr 15.
- Derived from this study: PubMed 23283923Bader JD, Vollmer WM, Shugars DA, Gilbert GH, Amaechi BT, Brown JP, Laws RL, Funkhouser KA, Makhija SK, Ritter AV, Leo MC. Results from the Xylitol for Adult Caries Trial (X-ACT). J Am Dent Assoc. 2013 Jan;144(1):21-30. doi: 10.14219/jada.archive.2013.0010.
- Derived from this study: PubMed 20920261Bader JD, Shugars DA, Vollmer WM, Gullion CM, Gilbert GH, Amaechi BT, Brown JP. Design of the xylitol for adult caries trial (X-ACT). BMC Oral Health. 2010 Sep 29;10:22. doi: 10.1186/1472-6831-10-22.
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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.
James D Bader, DDS MPH principal investigator
UNC School of Dentistry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing xylitol and inactive lozenge in people with Dental Caries, run by University of North Carolina, Chapel Hill at 3 sites 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 5 inclusion and 3 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
combined root and coronal D2FS (dental caries) increment (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393055, which also lists 4 linked publications.
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 12 Sep 2011.