Re-mineralizationNCT02468388
Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
A study testing maltitol, xylitol and gum base in people with Re-mineralization, run by Roquette Management (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Re-mineralization
- What is being tested?
- maltitol, xylitol and gum base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Jun 2012
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent Informed Consent Form signed by parent or legal guardian permitting participation of their children.
- Be cooperative and able to be examined in the whole study duration.
- Aged from 8 to 13 years.
- General Health: Good general health (in the opinion of the investigator) without clinically significant and relevant abnormalities of medical history such as diabetic, etc.
- Oral Health: Display 6 permanent front teeth and two maxillary buccal surfaces with visual evidence of active initial enamel carious lesions (de-mineralized but not cavitated); No any form of intraoral prostheses or appliances, clinical signs of severe gingivitis or periodontitis, temporomandibular joint disorders, and malocclusions or chronic onychophagia
- Oral Hygiene: have good oral health habits, brushing teeth at least once per day
- No medical or pharmacotherapy history that might affect the outcomes of the study, e.g. use of mouthwash, gels, or chewing gum containing antimicrobial agents during the previous 3 months
Who cannot join
- Disease: Presence of chronic debilitating disease, or any condition or other chronic disease which the investigators think not suitable for the study.
- Allergy/Intolerance: Be allergic to both maltitol and xylitol, oral care products, personal care consumer products, or their ingredients.
- Current Product Use: usual chewing-gum (of any kind) consumer or sugars-free candies consumer
- Clinical Study/Experiment: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
Trial locations and contacts
1 site in 1 country.
China1 site
West China College of Stomatology, Sichuan University
Sichuan, Sichuan, 610041
About this study
Official title: Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
The purpose of this study is to evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.
- Conditions
- Re-mineralization
- Being tested
- maltitol, xylitol, gum base
- Keywords
- maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maltitolOther
maltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day
xylitolOther
xylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day
gum baseOther
gum base: 99% gum base; two pellets for 10 min five times each day
| Study group | Role | What they receive |
|---|---|---|
| maltitol | Experimental | Not described Receives: Other: maltitol |
| xylitol | Active comparator | Not described Receives: Other: xylitol |
| gum base | Placebo comparator | Not described Receives: Other: gum base |
| no gum | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
Measured: baseline and 3 months
Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence
Measured: baseline and 6 months
Secondary outcomes (6)
Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip
Measured: baseline and 3 months
Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip
Measured: baseline and 6 months
Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter
Measured: baseline and 3 months
Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter
Measured: baseline and 6 months
Change from baseline in Silness & Loe Plaque index at 3 months
Measured: baseline and 3 months
Change from baseline in Silness & Loe Plaque index at 6 months
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-mineralizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roquette Management (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China College of Stomatology, Kaunas University of Medicine
- Responsible party
- Sponsor
- Investigators
- Deyu Hu, Ph.D., Principal investigator, West China College of Stomatology, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468388
- Sponsor's protocol ID
- CPS 10-341
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Chewing Sugar-free Gum on Re-mineralization of Early Caries Via Quantitative Light-induced Fluorescence
- ClinicalTrials.gov ID
- NCT02468388
- Acronym / sponsor ID
- CPS 10-341
- Conditions
- Re-mineralization
- Keywords
- maltitol, xylitol, quantitative light-induced fluorescence, saliva pH, re-mineralization, dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Roquette Management (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China College of Stomatology, Kaunas University of Medicine
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jun 2015 (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 evaluate the clinical effect of chewing gum containing maltitol, on re-mineralization of early caries following daily chewing for 6 months by school children, compared to a xylitol gum, gum base and a no gum group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| maltitol | Experimental | Other: maltitol |
| xylitol | Active comparator | Other: xylitol |
| gum base | Placebo comparator | Other: gum base |
| no gum | No intervention | – |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Consent Informed Consent Form signed by parent or legal guardian permitting participation of their children.
- Be cooperative and able to be examined in the whole study duration.
- Aged from 8 to 13 years.
- General Health: Good general health (in the opinion of the investigator) without clinically significant and relevant abnormalities of medical history such as diabetic, etc.
- Oral Health: Display 6 permanent front teeth and two maxillary buccal surfaces with visual evidence of active initial enamel carious lesions (de-mineralized but not cavitated); No any form of intraoral prostheses or appliances, clinical signs of severe gingivitis or periodontitis, temporomandibular joint disorders, and malocclusions or chronic onychophagia
Key exclusion criteria (4 listed)
- Disease: Presence of chronic debilitating disease, or any condition or other chronic disease which the investigators think not suitable for the study.
- Allergy/Intolerance: Be allergic to both maltitol and xylitol, oral care products, personal care consumer products, or their ingredients.
- Current Product Use: usual chewing-gum (of any kind) consumer or sugars-free candies consumer
- Clinical Study/Experiment: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
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 |
|---|---|---|
| maltitolmaltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day | Other | maltitol |
| xylitolxylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day | Other | xylitol |
| gum basegum base: 99% gum base; two pellets for 10 min five times each day | Other | gum base |
Primary outcome
Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence
Time frame: baseline and 3 months
Change from baseline in re-mineralization of early caries at 6 months measured by quantitative light-induced fluorescence
Time frame: baseline and 6 months
6 secondary outcomes
Change from baseline in Streptococcus mutans counts in saliva at 3 months measured by Dentocult strip
Time frame: baseline and 3 months
Change from baseline in Streptococcus mutans counts in saliva at 6 months measured by Dentocult strip
Time frame: baseline and 6 months
Change from baseline in Potential hydrogen (pH) of saliva at 3 months measured by pH meter
Time frame: baseline and 3 months
Change from baseline in Potential hydrogen (pH) of saliva at 6 months measured by pH meter
Time frame: baseline and 6 months
Change from baseline in Silness & Loe Plaque index at 3 months
Time frame: baseline and 3 months
Change from baseline in Silness & Loe Plaque index at 6 months
Time frame: baseline and 6 months
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 10 Jun 2015.
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.
Deyu Hu, Ph.D. principal investigator
West China College of Stomatology, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maltitol, xylitol and gum base in people with Re-mineralization, run by Roquette Management (Shanghai) Co., Ltd. at 1 site in China.
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 7 inclusion and 4 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 10 Jun 2015. 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 China. 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.
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?
Change from baseline in re-mineralization of early caries at 3 months measured by quantitative light-induced fluorescence (time frame: baseline and 3 months). 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 10 Jun 2015.