Enamel Subsurface LesionEarly Phase 1NCT01377493
Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel
A Early Phase 1 study testing chewing gum in people with Enamel Subsurface Lesion, run by Tokyo Medical and Dental University.
Trial summary
There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride. Read more about this study
- Who is it for?
- Ages 20 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Subsurface Lesion
- What is being tested?
- chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jun 2011
- Phase
- Early Phase 1
- 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 20 to 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult subjects
- More than 22 permanent teeth
Who cannot join
- Alcohol addiction
- Smoking
- Active caries
- Periodontal pockets
- Low-saliva flow (less than 0.3ml/min)
About this study
Official title: Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ
There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.
- Conditions
- Enamel Subsurface Lesion
- Being tested
- chewing gum
- Keywords
- chewing-gum, enamel subsurface lesion, calcium additives, fluoride, in situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumDietary supplement
chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: chewing gum |
| POs-Ca | Active comparator | Not described Receives: Dietary Supplement: chewing gum |
| POs-Ca+F | Active comparator | Not described Receives: Dietary Supplement: chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral content of enamel
Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enamel Subsurface LesionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical and Dental University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377493
- Sponsor's protocol ID
- 1B116
- Status last verified
- Jun 2011
- First submitted
- 17 Jun 2011
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.
PubMed 22337700Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.
PubMed 21875640
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ
- ClinicalTrials.gov ID
- NCT01377493
- Acronym / sponsor ID
- 1B116
- Conditions
- Enamel Subsurface Lesion
- Keywords
- chewing-gum, enamel subsurface lesion, calcium additives, fluoride, in situ
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tokyo Medical and Dental UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Jun 2011 (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.
There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: chewing gum |
| POs-Ca | Active comparator | Dietary Supplement: chewing gum |
| POs-Ca+F | Active comparator | Dietary Supplement: chewing gum |
Who may qualify
- Ages
- 20 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy adult subjects
- More than 22 permanent teeth
Key exclusion criteria (5 listed)
- Alcohol addiction
- Smoking
- Active caries
- Periodontal pockets
- Low-saliva flow (less than 0.3ml/min)
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 |
|---|---|---|
| chewing gumchewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions | Dietary supplement | POs-Ca, POs-Ca+F, placebo |
Primary outcome
Mineral content of enamel
Time frame: 2 weeks
Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed.
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 21 Jun 2011.
- Derived from this study: PubMed 22337700Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.
- Derived from this study: PubMed 21875640Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.
Related trials for Enamel Subsurface Lesion
Enrolling by invitationPhase 3
Clinical Study to Evaluate Remineralization Using an in Situ Model.
Remineralization, Enamel Lesions
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 Early Phase 1 study testing chewing gum in people with Enamel Subsurface Lesion, run by Tokyo Medical and Dental University.
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 2 inclusion and 5 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 21 Jun 2011. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Mineral content of enamel (time frame: 2 weeks). 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 NCT01377493, which also lists 2 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 21 Jun 2011.