Tooth DemineralizationNCT03971084
Impact of Chewing Gum With CPP-ACP on Tooth Mineralisation in Situ
A study testing Sugar free gum without CPP-ACP and Sugar free gum with CPP-ACP in people with Tooth Demineralization, run by Mondelēz International, Inc..
Trial summary
Monocentric, randomised, double-blind, cross-over controlled study with two arms. This study aims to analyse the impact on mineralisation of Sugar Free Gum (SFG) containing CPP-ACP in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Demineralization
- What is being tested?
- Sugar free gum without CPP-ACP and Sugar free gum with CPP-ACP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged between 18 and 55 years old (inclusive)
- Subject has read, signed and received a copy of the Informed Consent prior to initiation of study procedures
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits at their appointed time, and to use the product as per instructions
- Subject is in good general health based on medical history and oral soft and hard tissue examination
- Subject with normal salivary flow (unstimulated flow rate ≥0.3ml/min)
- Subject not disliking the taste of the SFG provided
- Subject with stable dietary habits and willing to consume 3 main meals per day with two extra-prandial intakes
- Healthy adults with a BMI value between 20 and 30 kg/m²
Who cannot join
- General criteria
- Subject under legal protection measure
- Subject deprived of liberty by a court or an administrative decision
- Subject currently participating in another study or being in the exclusion period of another study
- Biological, therapeutic and medical criteria
- Subject is pregnant, lactating or intend to become pregnant during the course of the clinical study based on oral interview only, as pregnancy may interfere with the outcome of the study
Show all 17Show fewer
- Subject has a systemic health condition and disorders (such as diabetes HIV positive, AIDS and systemic lupus erythematosis) that could affect the outcome of the study at the discretion of the Investigator
- Any active oral condition, such as caries, periodontal disease, chronic dental neglect or any oral pathology including xerostomia determined by oral evaluation and subject history that in the opinion of the dental examiner could affect the outcome of the study
- Subject has full or partial dentures or any orthodontic appliances (i.e. braces or use of night guards) or tongue or mouth piercing
- Use of other oral care products except the one provided by study team during the wash out period or during the treatment period
- Participation in a research study within the last 30 days
- Subjects treated with antibiotics during the last 30 days or other medications, which in the opinion of the Investigator might influence the study outcome
- Subjects with a history of sensitivity or allergies to ingredients in the study products or allergens present in the production facility (facility which also handles milk, egg, soy, peanut, tree nuts, wheat, fish, crustacean, mollusk, lupine, sesame, seeds, sulphites)Subjects with any concurrent illness, such as a cold, flu, upper respiratory infection, sinusitis or other infectious conditions
- Subjects under a restrictive diet or with a planned weight loss program during the study
- Subjects with severe eating disorders (e.g. anorexia nervosa, binge eating disorder and bulimia)
- Subjects without stable dietary habits or with specific dieting regime, for instance Atkins diet, gluten-free diet and additional specific diets at the discretion of the Investigator
- Subjects who smokes or vapes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Chewing Gum Containing CPP-ACP on Tooth Mineralisation, Using an in Situ Appliance in Healthy Subjects
Monocentric, randomised, double-blind, cross-over controlled study with two arms.
This study aims to analyse the impact on mineralisation of Sugar Free Gum (SFG) containing CPP-ACP in healthy adults.
Read the detailed description
There is some promising evidence in the literature to support a significant favourable impact of the consumption of Sugar Free Gum (SFG) containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on tooth mineralisation and especially on the promotion of tooth remineralisation, over and above the well-established role of regular SFG, in humans.
This study is a monocentric, randomised, double-blind, cross-over and controlled study. The research hypothesis is that chewing a SFG containing CPP-ACP from Recaldent will better remineralise the enamel in healthy subjects compared with regular SFG, after 2 weeks of gum chewing 5 times a day for 20 minutes within 5 minutes after each meal and snack occasion, with a CPP-ACP dose of 18.8 mg per SFG. This will be studied with an in situ model study, with palatal appliances bearing recessed (1,5mm) human demineralised enamel blocks with caries-like lesions (subsurface lesions), which should be worn 24 h a day by the subjects, including during eating and drinking (but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself). Each appliance will contain two types of the demineralised enamel blocks: half of the blocks will contain shallow subsurface lesions (Carbopol method) and the other half reflecting deeper subsurface lesions (hydroxy-ethyl cellulose method). Both types of lesions have been the subject of oral research interest, as both shallow and deep lesions are involved in caries genesis. Changes in mineralisation of the lesions will be assessed using Transverse Microradiography (TMR).
- Conditions
- Tooth Demineralization
- Being tested
- Sugar free gum without CPP-ACP, Sugar free gum with CPP-ACP
- Keywords
- casein phosphopeptide-amorphous calcium phosphate, CPP-ACP, in situ appliance, Transverse Microradiography, TMR, Recaldent, Tooth Remineralization
- Medical subject headings
- Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar free gum without CPP-ACPOther
Sugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
Sugar free gum with CPP-ACPOther
Also called Recaldent
Sugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Sugar free gum without CPP-ACP | Placebo comparator | Sugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. Receives: Other: Sugar free gum without CPP-ACP |
| Sugar free gum with CPP-ACP | Active comparator | Sugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. Receives: Other: Sugar free gum with CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Secondary outcomes (17)
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compliance to the number of chewing-gum consumption per day
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compliance to the length of chewing-gum occasion
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Compliance to the number of meal and snack consumption per day
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
Comparison between the 2 groups
Measured: After 2 weeks intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study startOct 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DemineralizationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Monocentric, randomised, double-blind, cross-over controlled study with two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Susan M. Higham, Prof., Principal investigator, The University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971084
- Sponsor's protocol ID
- KBE057
- Status last verified
- Oct 2021
- First submitted
- 22 May 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chewing Gum Containing CPP-ACP on Tooth Mineralisation, Using an in Situ Appliance in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03971084
- Acronym / sponsor ID
- KBE057
- Conditions
- Tooth Demineralization
- Keywords
- casein phosphopeptide-amorphous calcium phosphate, CPP-ACP, in situ appliance, Transverse Microradiography, TMR, Recaldent, Tooth Remineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Liverpool
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Jun 2019 (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.
Monocentric, randomised, double-blind, cross-over controlled study with two arms.
This study aims to analyse the impact on mineralisation of Sugar Free Gum (SFG) containing CPP-ACP in healthy adults.
Detailed description
There is some promising evidence in the literature to support a significant favourable impact of the consumption of Sugar Free Gum (SFG) containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on tooth mineralisation and especially on the promotion of tooth remineralisation, over and above the well-established role of regular SFG, in humans.
This study is a monocentric, randomised, double-blind, cross-over and controlled study. The research hypothesis is that chewing a SFG containing CPP-ACP from Recaldent will better remineralise the enamel in healthy subjects compared with regular SFG, after 2 weeks of gum chewing 5 times a day for 20 minutes within 5 minutes after each meal and snack occasion, with a CPP-ACP dose of 18.8 mg per SFG. This will be studied with an in situ model study, with palatal appliances bearing recessed (1,5mm) human demineralised enamel blocks with caries-like lesions (subsurface lesions), which should be worn 24 h a day by the subjects, including during eating and drinking (but the appliances should be removed for daily oral hygiene procedure and cleaning of the appliance itself). Each appliance will contain two types of the demineralised enamel blocks: half of the blocks will contain shallow subsurface lesions (Carbopol method) and the other half reflecting deeper subsurface lesions (hydroxy-ethyl cellulose method). Both types of lesions have been the subject of oral research interest, as both shallow and deep lesions are involved in caries genesis. Changes in mineralisation of the lesions will be assessed using Transverse Microradiography (TMR).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, randomised, double-blind, cross-over controlled study with two arms
| Arm | Type | Receives |
|---|---|---|
| Sugar free gum without CPP-ACP | Placebo comparator | Other: Sugar free gum without CPP-ACPSugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. |
| Sugar free gum with CPP-ACP | Active comparator | Other: Sugar free gum with CPP-ACPSugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults aged between 18 and 55 years old (inclusive)
- Subject has read, signed and received a copy of the Informed Consent prior to initiation of study procedures
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits at their appointed time, and to use the product as per instructions
- Subject is in good general health based on medical history and oral soft and hard tissue examination
- Subject with normal salivary flow (unstimulated flow rate ≥0.3ml/min)
Key exclusion criteria (17 listed)
- General criteria
- Subject under legal protection measure
- Subject deprived of liberty by a court or an administrative decision
- Subject currently participating in another study or being in the exclusion period of another study
- Biological, therapeutic and medical criteria
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 |
|---|---|---|
| Sugar free gum without CPP-ACPSugar free gum without CPP-ACP, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. | Other | Sugar free gum without CPP-ACP |
| Sugar free gum with CPP-ACPAlso: RecaldentSugar free gum with 18.8 mg CPP-ACP per gum, consumed 5 times a day, for 20 min each time, within 5 minutes after 3 main meals plus 2 snacks occasion, during 14 days. | Other | Sugar free gum with CPP-ACP |
Primary outcome
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Comparison between the 2 groups
17 secondary outcomes
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by Carbopol method
Time frame: After 2 weeks intervention period
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
Time frame: After 2 weeks intervention period
Compliance to the number of chewing-gum consumption per day
Time frame: After 2 weeks intervention period
Compliance to the length of chewing-gum occasion
Time frame: After 2 weeks intervention period
Compliance to the number of meal and snack consumption per day
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
Time frame: After 2 weeks intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Susan M. Higham, Prof. principal investigator
The University of Liverpool
Questions about this trial
What is this clinical trial studying?
A study testing Sugar free gum without CPP-ACP and Sugar free gum with CPP-ACP in people with Tooth Demineralization, run by Mondelēz International, Inc..
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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gleb N. Komarov, Dr (+441517065511, komarovg@liv.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method (time frame: After 2 weeks intervention period). 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 18 Oct 2021.