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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02999230




Registration number
NCT02999230
Ethics application status
Date submitted
13/12/2016
Date registered
21/12/2016

Titles & IDs
Public title
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Scientific title
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Secondary ID [1] 0 0
5R01DE025832-05
Secondary ID [2] 0 0
IRB201602471-N
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Caries Free 1.5% Arginine
Other interventions - Caries Free Placebo Sodium Fluoride
Other interventions - Caries Active 1.5% Arginine
Other interventions - Caries Active- Placebo Sodium Fluoride

Active comparator: Caries Free - Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.

Placebo comparator: Caries Free- Placebo - Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Active comparator: Caries Active - Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.

Placebo comparator: Caries Active- Placebo - Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.


Other interventions: Caries Free 1.5% Arginine
Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Other interventions: Caries Free Placebo Sodium Fluoride
Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Other interventions: Caries Active 1.5% Arginine
Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Other interventions: Caries Active- Placebo Sodium Fluoride
Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
Timepoint [1] 0 0
Changes from baseline to 2 weeks (Screening)
Primary outcome [2] 0 0
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
Timepoint [2] 0 0
Changes from week 2 to week 4 (Baseline)
Primary outcome [3] 0 0
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8
Timepoint [3] 0 0
Changes from week 4 to week 8 (Washout)
Primary outcome [4] 0 0
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
Timepoint [4] 0 0
Changes from week 8 to week 12 (Evaluation)
Primary outcome [5] 0 0
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
Timepoint [5] 0 0
Changes from baseline to week 12 (Evaluation)
Secondary outcome [1] 0 0
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
Timepoint [1] 0 0
Changes from baseline to week 2
Secondary outcome [2] 0 0
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
Timepoint [2] 0 0
Changes from week 2 to week 4
Secondary outcome [3] 0 0
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8
Timepoint [3] 0 0
Changes from week 4 to week 8
Secondary outcome [4] 0 0
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12
Timepoint [4] 0 0
Changes from week 8 to week 12
Secondary outcome [5] 0 0
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
Timepoint [5] 0 0
Changes from baseline to week 12

Eligibility
Key inclusion criteria
* Twenty natural uncrowned teeth excluding third molars
* No contraindications to dental treatment
* Caries Free-(with no clinical evidence of past or present caries)
* Caries Active- (At least two active sites)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Less than 20 teeth
* Systemic disease that can cause xerostomia
* Taking medication known to cause xerostomia
* Have been treated with antibiotics within the past 3 months
* Advanced periodontal disease
* Removable or fixed dental appliances
* Bleeding disorders or taking anticoagulant medications
* Immune compromised individuals
* Uses tobacco products
* Participation in another clinical study one week prior to the start of the washout period or during the study period
* Use of any flavored products, such as mint flavored candies and chewing gum, one week prior to or during the study
* Unwilling or unable to provide informed consent and follow plaque/saliva collection instructions

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2020
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
University of Florida
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Dental and Craniofacial Research (NIDCR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcelle Nascimento, DDS, MS PhD
Address 0 0
University of Florida
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02999230