Status unknownNCT03971084Updated Oct 18, 2021

Impact of Chewing Gum With CPP-ACP on Tooth Mineralisation in Situ

An interventional study of Sugar free gum without CPP-ACP and Sugar free gum with CPP-ACP in Tooth Demineralization, sponsored by Mondelēz International, Inc.. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 14
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 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 studied

Tooth Demineralization

Browse trials for

Tooth Demineralization 27

Keywords

casein phosphopeptide-amorphous calcium phosphate
CPP-ACP
in situ appliance
Transverse Microradiography, TMR
Recaldent
Tooth Remineralization

In context

Tooth Demineralization

27 studies on the registry are indexed under Tooth Demineralization; 9 are open to participants now.

This study's planned enrollment of 14 is below the median of 40 across 27 interventional studies indexed under Tooth Demineralization.

Browse Tooth Demineralization studies →

Lead sponsor

Mondelēz International, Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Browse Mondelēz International, Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy adults aged between 18 and 55 years old (inclusive)
Subject has read, signed and received a copy of the 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 value between 20 and 30 kg/m²

Exclusion criteria

Exclusion Criteria:

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
Subject has a systemic health condition and disorders (such as diabetes 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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 14 participants (estimated)

Study arms

Placebo comparator
Sugar free gum without CPP-ACP
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.
Other: Sugar free gum without CPP-ACP
Active comparator
Sugar free gum with CPP-ACP
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.
Other: Sugar free gum with CPP-ACP

Interventions

OtherSugar free gum without CPP-ACP
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.
OtherSugar free gum with CPP-ACP
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.
Also known as: Recaldent

What researchers measure

Primary outcomes

Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
Comparison between the 2 groups
Time frame: After 2 weeks intervention period

Secondary outcomes

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
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
Comparison between the 2 groups
Time frame: 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
Time frame: 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
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
Comparison between the 2 groups
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
Comparison between the 2 groups
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
Comparison between the 2 groups
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
Comparison between the 2 groups
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
Comparison between the 2 groups
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
Comparison between the 2 groups
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
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the number of chewing-gum consumption per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the length of chewing-gum occasion
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Compliance to the number of meal and snack consumption per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
Comparison between the 2 groups
Time frame: After 2 weeks intervention period
Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
Comparison between the 2 groups
Time frame: After 2 weeks intervention period

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2021; primary completion for Jun 2022, 8 months later.

Of 16 interventional studies with no phase under Tooth Demineralization, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: May 22, 2019
First posted: Jun 3, 2019
StartEst.: Oct 2021
Primary completionEst.: Jun 2022
CompletionEst.: Dec 2022
Last update: Oct 18, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03971084
Lead sponsor: Mondelēz International, Inc.
Collaborators: University of Liverpool
Responsible party: Sponsor
First posted: Jun 3, 2019
Start date: Oct 2021 (estimated)
Primary completion: Jun 2022 (estimated)
Completion: Dec 2022 (estimated)
Last update: Oct 18, 2021

Study contacts

Gleb N. Komarov, Dr

Contact

komarovg@liv.ac.uk

+441517065511

Aurelie Goux, Dr

Contact

aurelie.goux@mdlz.com

+33183114620

Susan M. Higham, Prof.

principal investigator · The University of Liverpool

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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