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Trial registered on ANZCTR


Registration number
ACTRN12623000893606
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
21/08/2023
Date last updated
20/09/2024
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Prebiotic Effect of New Dentifrice Formulations In Healthy Adults
Scientific title
Effect of a Toothpaste containing Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) and Stannous Fluoride on Supragingival Plaque Composition and Gingivitis in Healthy Adults
Secondary ID [1] 310321 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 331040 0
Condition category
Condition code
Oral and Gastrointestinal 327836 327836 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will brush their teeth with the allocated toothpaste (i.e., one of the test products) three times per day for 21 consecutive days at the following times: after breakfast, after dinner and before retiring. Participants will use an amount of toothpaste to completely cover the bristles on their toothbrush. The participants will then brush their teeth for two minutes ensuring they brush all tooth surfaces. After toothbrushing the participants will not eat or drink for 30 minutes.
A diary will be provided for each participant to record the times of administration of intervention treatment (i.e., toothbrushing with their allocated toothpaste) each day during the treatment period and returned at the completion of the study.
Intervention code [1] 326699 0
Treatment: Other
Comparator / control treatment
Marketed Control: Colgate Total SF toothpaste containing stannous fluoride (1100 ppm F).

Participants will brush their teeth for two minutes with Colgate Total SF toothpaste three times a day after breakfast, after dinner and before bed, with no other oral hygiene procedures over 21 days.
A diary will be provided for each participant to record their interventions and compliance during the treatment period and returned at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 335685 0
Change in gingivitis.

Tools/tests to be used for assessment:
Clinical examination will be performed at the start and finish of the treatment period by a trained dentist.
Gingivitis will be measured using the Modified Gingival Index (MGI – Lobene et al., 1986). This index is a modification of the Löe and Silness (1963) Gingival Index and allows greater discrimination for mild and moderate gingivitis. In this study, gingival inflammation on a scale from 0 to 4 will be scored for gingival tissues associated with four sites (buccal, lingual, mesial and distal) of all teeth (excluding third molars).
Timepoint [1] 335685 0
Baseline before intervention, and 21 days post-intervention commencement.
Secondary outcome [1] 425178 0
Change in bleeding on probing.
Tools/tests to be used for assessment:
Clinical examination will be performed at the start and finish of the treatment period by a trained dentist.
Bleeding on probing will be scored using the Sulcus Bleeding Index (SBI – Muhlemann and Son, 1971).
Four gingival units are scored systematically for each tooth: the labial and lingual marginal gingival (M units) and the mesial and distal papillary gingival (P units). Scores for these units are added and divided by four. Adding the scores of the undivided teeth and dividing them by the number of teeth can determine the sulcus bleeding index.
Timepoint [1] 425178 0
Baseline before intervention, and 21 days post-intervention commencement.
Secondary outcome [2] 425476 0
Development of supragingival plaque.
Tools/tests to be used for assessment:
Clinical examination will be performed at the start and finish of the treatment period by a trained dentist..Supragingival plaque will be collected from the buccal surfaces of the maxillary molars
Supragingival plaque will be assessed using the Turesky modification of the Quigley-Hein Index (TPI – Turesky et al., 1970). This index is recognized as a reliable estimate of the tooth area covered by plaque and is frequently used for evaluating anti-plaque agents. Plaque scores associated with unrestored labial, buccal and lingual surfaces of all teeth, except third molars will be assessed. Each surface will be assigned a score from 0 to 5.
The plaque index is obtained by adding the scores for each tooth and dividing by the number of surfaces examined.
Timepoint [2] 425476 0
Baseline before intervention, and 21 days post-intervention commencement.
Secondary outcome [3] 425482 0
Shift in microbial composition of the supragingival plaque formed on the maxillary molars.
Tools/tests to be used for assessment:
Clinical examination will be performed at the start and finish of the treatment period by a trained dentist. Supragingival plaque will be collected from the buccal surfaces of the maxillary molars. Genomic DNA will be extracted from the supragingival plaque using a combination of mechanical disruption of the cells via a Precellys homogeniser and the chemical extraction and purification of the genomic DNA via the PowerLyzer PowerSoil DNA Isolation Kit (MoBio). Quantitation of the extracted DNA will be achieved using a Qubit dsDNA High Sensitivity Assay kit (ThermoFisher), before 5 ng DNA is used as template in a PCR reaction that amplifies the V1-V3 variable region of the 16S ribosomal RNA gene and individually barcodes the PCR product from each sample. The barcoded DNA will then be sequenced using an Ion Torrent Personal Genome machine and Torrent Suite™ Software (ThermoFisher).
Timepoint [3] 425482 0

Baseline before intervention, and 21 days post-intervention commencement.

Eligibility
Key inclusion criteria
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Ability to understand, and willingness and ability to read and sign, the informed consent form.
2. Age range: 18 to 75 years old.
3. Good general health.
4. Minimum of 20 natural teeth.
5. A gum-stimulated whole salivary flow rate greater than or equal to 1.0 ml/minute and unstimulated whole salivary flow rate greater than or equal to 0.2 ml/minute.
6. A baseline mean whole-mouth modified gingival index greater than or equal to 1.2.
7. A baseline mean whole-mouth plaque index greater than or equal to 1.5.
8. 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:
Individuals who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study:
1. Allergy to milk protein, tin or other ingredients in toothpaste products.
2. Orthodontic appliances or removable prostheses.
3. Veneers, or more than one incisor with a prosthetic crown.
4. Gross oral pathology (including periodontal disease {Community Periodontal Index of Treatment Needs [CPITN] greater than or equal to 3} and tumours of the soft or hard oral tissues).
5. Chronic disease with concomitant oral manifestations (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia).
6. Unrestored dentinal caries.
7. Treatment with antibiotics or anti-inflammatory medication in the month prior to starting the study.
8. Concomitant pharmacotherapy with drugs that may interact with test drug.
9. History of conditions requiring antibiotic coverage prior to invasive dental procedures.
10. Pregnancy/lactation.

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
10/10/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
40
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41054 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 314527 0
University
Name [1] 314527 0
Centre of Oral Health Research
Country [1] 314527 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Melbourne, Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 316484 0
None
Name [1] 316484 0
Address [1] 316484 0
Country [1] 316484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313569 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 313569 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] 313569 0
Australia
Date submitted for ethics approval [1] 313569 0
16/08/2023
Approval date [1] 313569 0
22/09/2023
Ethics approval number [1] 313569 0

Summary
Brief summary
This examiner-blinded, randomized controlled clinical trial will use a two-treatment, parallel design to assess the effects of the treatments on the severity of gingivitis, accumulation of supragingival plaque and changes in the microbial composition of supragingival plaque. Participants will be randomly assigned to one of two treatments with each treatment comprising 21 days. The two treatments will be as follows:
A. Tooth brushing with GC MI Paste One Perio containing 10% CPP-ACP and stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days.
B. Tooth brushing with Colgate Total SF containing stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days.
During the treatment period, all participants will be requested not to brush with any other toothpaste and not to consume any antibiotics or antimicrobials including antimicrobial mints, lozenges, films and chewing gums.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128582 0
Prof Eric Reynolds
Address 128582 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 128582 0
Australia
Phone 128582 0
+61 3 9341 1547
Fax 128582 0
Email 128582 0
[email protected]
Contact person for public queries
Name 128583 0
Eric Reynolds
Address 128583 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 128583 0
Australia
Phone 128583 0
+61 3 9341 1547
Fax 128583 0
Email 128583 0
[email protected]
Contact person for scientific queries
Name 128584 0
Eric Reynolds
Address 128584 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Melbourne, Victoria 3010
Australia
Country 128584 0
Australia
Phone 128584 0
+61 3 9341 1547
Fax 128584 0
Email 128584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.