Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001081707p
Ethics application status
Not yet submitted
Date submitted
16/07/2022
Date registered
4/08/2022
Date last updated
4/08/2022
Date data sharing statement initially provided
4/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effects of sugar free chewing gums containing oral care agent on early tooth decay.
Scientific title
Evaluation of the ability of sugar free chewing gum containing 5mg and 10mg casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) to remineralize enamel subsurface lesions in a human in situ model
Secondary ID [1] 307600 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 327042 0
Condition category
Condition code
Oral and Gastrointestinal 324218 324218 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to determine the ability of sugar-free gum containing 0, 5mg and 10mg CPP-ACP (Recaldent ®) to remineralize (repair) subsurface enamel lesions in situ.
The sugar free chewing gums containing Recaldent will be provided by Mondelez as coded products in sealed packages and will be stored at room temperature. The code will be held by an independent group and not released until all the data has been acquired. Three randomized treatments (A, B and C) will consist of sugar free chewing gums containing 0, 5mg and 10mg Recaldent.
A palatal appliance for each participant will be prepared by taking alginate impressions of upper and lower dental arches from which study models will be produced and articulated. For the preparation of the palatal appliance, it will need each participant a single approximately 20 minute visit to the study clinic around three weeks before starting treatment. Removable palatal acrylic appliances covering the first premolars to the last tooth in the arch will be fabricated for each participant. The palatal appliance will consist of a palatal plate that will be retained in the mouth by four stainless steel clasps. Troughs on each side of the palatal appliance adjacent to the palatal surface of maxillary premolar/molar teeth will each accommodate four enamel half-slabs, each containing two demineralized subsurface lesions. Therefore, each appliance will contain four enamel half-slabs. The enamel slabs will be inset into the bilateral troughs of the palatial appliance. The appliances will be designed to ensure their surfaces are smooth and comfortable for the participants.
There will be one week washout period before the first treatment. Participants will be instructed to insert their appliances immediately before gum-chewing for 20 min and then retain their appliance in the mouth for another 20 min with their appliances worn 40 min each time. This will be performed four times daily at the following times: 10.00am, 11:30am, 2.00pm and 3:30pm each day for 14 consecutive days including weekends and it will be recorded in participant’s diaries. At all other times, the appliances will be stored in sealed moist plastic bags at room temperature. All participants will cross over to each randomly assigned treatment, with at least one week washout period between treatments.
Participants will use standard fluoride dentifrice provided to brush their teeth twice daily (morning and evening) to replace their current toothpaste/teeth-brushing habits for the duration of the clinical study and all washout periods. During a clinical trial period, participants will be instructed not to eat or drink while wearing the appliance and to rinse and clean their appliances using a fluoride-free denture cleanser paste and toothbrush provided. They will be informed not to brush the area containing the enamel blocks. No alterations will be made the participants’ diet and oral hygiene procedures for the duration of the clinical study. After completion of each treatment period, the enamel blocks will be removed from the appliances for processing and measurement of remineralisation of enamel subsurface lesions.
The study will be carried out at Melbourne Dental School, University of Melbourne at Royal Dental Hospital of Melbourne.
Intervention code [1] 324046 0
Treatment: Other
Comparator / control treatment
The "comparator" is the sugar free chewing gum containing 0mg Recaldent.
Control group
Active

Outcomes
Primary outcome [1] 332033 0
Remineralisation of artificially-created enamel subsurface carious lesions measured by calculating the difference in mineral content of lesions exposed to the chewing gums containing 0, 5mg and 10mg Recaldent, using microdensitometric analysis of microradiographic images of the lesions.
Timepoint [1] 332033 0
14 days post-intervention commencement.
Secondary outcome [1] 411949 0
The secondary outcomes will be:
• the changes in the densitometric profile of the remineralized lesions (Zd–Zr) after treatment with sugar free gum containing 0, 5mg and 10mg CPP-ACP (Recaldent ®).

The methodology for the densitometric profile analysis is as follows:
At the completion of each treatment period, the enamel test half-slabs will be removed from the appliances in the research lab and paired with its demineralization control half-slabs, embedded, sectioned for transverse microradiograph (TMR) image analysis to measure enamel subsurface lesion mineral content changes.
Timepoint [1] 411949 0
14 days post-intervention commencement.
Secondary outcome [2] 412027 0

• the changes in lesion depth of the remineralized lesion (LDd–LDr) after treatment with sugar free gum containing 0, 5mg and 10mg CPP-ACP (Recaldent ®).

The methodology for measurement of the changes in lesion depth after each treatment is as follows:
At the completion of each treatment period, the enamel test half-slabs will be removed from the appliances in the research lab and paired with its demineralization control half-slabs, embedded, sectioned for transverse microradiograph (TMR) image analysis, using imaging software Image Pro Plus Version 7.0, to measure enamel subsurface lesion depth changes after each treatment.
Timepoint [2] 412027 0
14 days post-intervention commencement.

Eligibility
Key inclusion criteria
Inclusion Criteria
To be included in the study, each participant must:
• Be 18-75 years of age;
• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be in good general health based on medical/dental history and oral exam;
• Have no history of adverse or allergic reactions to milk or casein-containing products (such as casein phosphopeptides);
• Agree not to participate in any other oral study for the study duration;
• Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance;
• Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time;
• Be willing to refrain from using non-study dentifrice, mouth rinse, and other non-study chewing gums and other oral care products during the study.

In addition, to be eligible to participate in this study, an individual must also meet ALL the following criteria:
• Ability to understand, and ability to read and sign, the informed consent form;
• Have at least 22 natural teeth;
• Have a gum-stimulated whole salivary flow rate > 1.0 ml/minute and unstimulated whole salivary flow rate > 0.2 ml/minute.
• Willingness to comply with all study procedures and be available for the duration of the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
Participants are excluded from study participation where there is evidence of:
• Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
• Active treatment for periodontitis;
• A medical condition which requires premedication prior to dental visits/procedures;
• Untreated dental problems (e.g. cavities);
• Self-reported pregnancy or plans to become pregnant during the study;
• Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
• Chronic disease such as diabetes or use of medications that cause gum swelling;
• Any diseases or conditions that might interfere with examination procedures or the participant safely completing the study;
• Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
• Use of drugs that may affect salivary flow rate;
• History of health conditions requiring antibiotic coverage prior to dental treatment;
• Serious infectious disease;
• Any other medical or dental conditions deemed to put the health and wellbeing of the participant or research team at risk if the potential participant participated in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38143 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 311869 0
University
Name [1] 311869 0
Oral Health CRC, University of Melbourne
Country [1] 311869 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville Victoria 3010
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 313344 0
None
Name [1] 313344 0
Address [1] 313344 0
Country [1] 313344 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311306 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 311306 0
Office of Research Ethics and Integrity | Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010, Australia
Ethics committee country [1] 311306 0
Australia
Date submitted for ethics approval [1] 311306 0
29/08/2022
Approval date [1] 311306 0
Ethics approval number [1] 311306 0

Summary
Brief summary
The study is to compare the remineralisation (repair) of early decay-like lesions in tooth treated with sugar free chewing gums containing 0, 5mg and 10mg CPP-ACP (Recaldent) in a randomized, double-blind trial. All participants will wear palatal appliances with attached enamel slabs during each 14 -day treatment period. This study hypothesis is that there is no significant difference between treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120646 0
Prof Eric Reynolds
Address 120646 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 120646 0
Australia
Phone 120646 0
+61 3 9341 1547
Fax 120646 0
Email 120646 0
e.reynolds@unimelb.edu.au
Contact person for public queries
Name 120647 0
Prof Eric Reynolds
Address 120647 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 120647 0
Australia
Phone 120647 0
+61 3 9341 1547
Fax 120647 0
Email 120647 0
e.reynolds@unimelb.edu.au
Contact person for scientific queries
Name 120648 0
Prof Eric Reynolds
Address 120648 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 120648 0
Australia
Phone 120648 0
+61 3 9341 1547
Fax 120648 0
Email 120648 0
e.reynolds@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD data will not be available due to privacy concerns as this study involves only a small number of participants and the potential for data matching with previous studies conducted by the Institution.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16660Informed consent form    384397-(Uploaded-16-07-2022-21-45-49)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.