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

NCT03971084 | Unknown

• 1 other identifier: KBE057
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Demineralization

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Comparison between the 2 groups

  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

  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

  After 2 weeks intervention period

• Compare the percent mineral change (%R) measured by Transverse Microradiography on subsurface lesions created by Carbopol method

  After 2 weeks intervention period

• Compare the lesion depth (LD) measured by Transverse Microradiography on subsurface lesions created by Carbopol method

  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

  After 2 weeks intervention period

Study Arms (2)

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.

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.

Other: Sugar free gum with CPP-ACP

Interventions

Sugar free gum without CPP-ACP OTHER

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 without CPP-ACP

Sugar free gum with CPP-ACP OTHER

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

Sugar free gum with CPP-ACP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• General criteria
• Subject under legal protection measure
• Subject deprived of liberty by a court or an administrative decision
• 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

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• University of Liverpool: collaborator

MeSH Terms

Conditions

Tooth Demineralization

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Susan M. Higham, Prof.

  The University of Liverpool

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gleb N. Komarov, Dr

CONTACT

+441517065511; komarovg@liv.ac.uk

Aurelie Goux, Dr

CONTACT

+33183114620; aurelie.goux@mdlz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Same sugar free gum appearance, labelling differ with a letter (A or B)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, randomised, double-blind, cross-over controlled study with two arms

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 3, 2019
• Study Start: October 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share