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

Primary Purpose

Tooth Demineralization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sugar free gum without CPP-ACP
Sugar free gum with CPP-ACP
Sponsored by
Mondelēz International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tooth Demineralization focused on measuring casein phosphopeptide-amorphous calcium phosphate, CPP-ACP, in situ appliance, Transverse Microradiography, TMR, Recaldent, Tooth Remineralization

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Sugar free gum without CPP-ACP

    Sugar free gum with CPP-ACP

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
    Comparison between the 2 groups

    Secondary Outcome Measures

    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
    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
    Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Comparison between the 2 groups
    Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Comparison between the 2 groups
    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
    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
    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
    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
    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
    Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Comparison between the 2 groups
    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
    Compliance to the number of chewing-gum consumption per day
    Comparison between the 2 groups
    Compliance to the length of chewing-gum occasion
    Comparison between the 2 groups
    Compliance to the number of meal and snack consumption per day
    Comparison between the 2 groups
    Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
    Comparison between the 2 groups
    Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
    Comparison between the 2 groups
    Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
    Comparison between the 2 groups

    Full Information

    First Posted
    May 22, 2019
    Last Updated
    October 15, 2021
    Sponsor
    Mondelēz International, Inc.
    Collaborators
    University of Liverpool
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03971084
    Brief Title
    Impact of Chewing Gum With CPP-ACP on Tooth Mineralisation in Situ
    Official Title
    Impact of Chewing Gum Containing CPP-ACP on Tooth Mineralisation, Using an in Situ Appliance in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mondelēz International, Inc.
    Collaborators
    University of Liverpool

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Demineralization
    Keywords
    casein phosphopeptide-amorphous calcium phosphate, CPP-ACP, in situ appliance, Transverse Microradiography, TMR, Recaldent, Tooth Remineralization

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Monocentric, randomised, double-blind, cross-over controlled study with two arms
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Same sugar free gum appearance, labelling differ with a letter (A or B)
    Allocation
    Randomized
    Enrollment
    14 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sugar free gum without CPP-ACP
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Sugar free gum with CPP-ACP
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Sugar free gum without CPP-ACP
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Sugar free gum with CPP-ACP
    Other Intervention Name(s)
    Recaldent
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Secondary Outcome Measure Information:
    Title
    Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by Carbopol method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the relative mineral weight content measured by Transverse Microradiography (DeltaZd-DeltaZr) on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the densitometric profile of the demineralised lesion (Delta Zd) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the densitometric profile of the remineralised lesion (Delta Zr) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compare the change in lesion depth (LDd - LDr) after treatment measured by Transverse Microradiography on subsurface lesions created by hydroxy-ethyl cellulose (HEC) method
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compliance to the number of chewing-gum consumption per day
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compliance to the length of chewing-gum occasion
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Compliance to the number of meal and snack consumption per day
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Evaluation the compliance to oral appliance wearing (length of appliance wearing per day)
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Evaluation the compliance to oral hygiene compliance: number of oral procedures per day
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period
    Title
    Evaluation the compliance to oral hygiene compliance: weight of unused toothpaste
    Description
    Comparison between the 2 groups
    Time Frame
    After 2 weeks intervention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gleb N. Komarov, Dr
    Phone
    +441517065511
    Email
    komarovg@liv.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aurelie Goux, Dr
    Phone
    +33183114620
    Email
    aurelie.goux@mdlz.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan M. Higham, Prof.
    Organizational Affiliation
    The University of Liverpool
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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