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Trial registered on ANZCTR

Registration number

ACTRN12607000653460

Ethics application status

Approved

Date submitted

19/12/2007

Date registered

20/12/2007

Date last updated

29/06/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

The repair of early tooth decay after rinsing with two solutions, one containing fluoride and a major component of milk called casein, and another containing fluoride only.

Scientific title

The Remineralization of Subsurface Enamel Carious Lesions in situ by Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) and 900 ppm fluoride in Tooth Mousse Plus™, and 5000 ppm fluoride in Neutrafluor 5000™

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Early (subsurface) enamel caries

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Rinsing with 1:4 dilutions in distilled deionized water of: 1) a tooth creme product containing 10% weight per volume(w/w) casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and 900 parts per million (ppm) sodium fluoride (final concentration 2% (w/v) CPP-ACP and 180 ppm fluoride); 2) an oral care product containing 5000 ppm sodium fluoride (final concentration 1000 ppm fluoride).
The subjects will each wear an upper removable custom-made denture-like appliance that will hold four pre-sterilized enamel pieces each. These enamel pieces will contain artificially-created subsurface carious lesions. The appliances with attached enamel pieces will be worn by the subjects for 40 minutes four times a day for 10 consecutive days and worn immediately before rinsing with the solution. Subjects will also rinse with the solution for 60 seconds four times a day immediately after inserting the appliance each time. After 10 days, the enamel pieces will be removed from the appliance and replaced with new enamel pieces containing the subsurface lesions for the next treatment period.
This is a cross over trial - each participant will rinse with either the intervention or control solution (randomly allocated) for the first 10 days and then crossover to rinse with the other solution for another 10 days after a four day washout period between.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Mouthrinse made from 1:4 dilution in distilled deionized water of a commercially-available oral care product containing 5000 ppm fluoride (mouthrinse therefore contains 1000 ppm fluoride).
Subjects will rinse with this solution four times a day, for 60 seconds each time, over 10 consecutive days.
Subjects will wear the appliances holding pre-sterilized enamel pieces containing artificially-created subsurface carious lesions as per the intervention group.

Control group

Active

Outcomes

Primary outcome [1]

Remineralization of artificially-created subsurface carious lesions measured by calculating the difference in mineral content in lesions exposed to the solutions and the mineral content of the respective control lesions (not exposed to the solutions), using microdensitometric analysis of microradiographic images of the lesions.

Timepoint [1]

Mineral content will be measured once at the end of 10 days' rinsing with each of the two solutions.

Secondary outcome [1]

N/A

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

Adults in good general and dental health
Have at least 22 teeth
Produce normal amounts of saliva (determined by measuring the volume of a two-minute unstimulated saliva sample and a two-minute stimulated saliva sample).

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Allergic or adverse reactions to milk or milk products.
History of dry mouth, or medical conditions or taking medication likely to cause xerostomia.
Bleeding disorders.
Infectious diseases including blood-borne diseases such as HIV/AIDS; or Hepatitis C.
Active dental caries or periodontal diseases.
History of rheumatic heart disease, heart murmurs, etc. where risk of complications following bacteremia is present.
pregnancy.

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)

The institution will be provided with the products in packets as they are marketed. Participants will be enrolled after they have fulfilled inclusion criiteria and do not have any of the medical or dental conditions that would exclude them from the study. They will sign a written consent form before participating. Allocation of products to participants will be random. Each participant will be given a coded plastic tube each day containing freshly prepared solution allocated to them. The code will only be known to researchers preparing the solutions from these products to give to the participants. Therefore, the sequence of treatments for each subject will only be known to the researchers preparing the solutions and not the participants or the researchers measuring mineral content in the enamel lesions or analyzing the remineralization data collected. In the case of a medical emergency, the code can be accessed for a single participant without breaking the blinding for other participants.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated randomization procedure.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

This a two-way crossover study with a washout period of four days between treatments.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/11/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Co-operative Research Centre for Oral Health Sciences

Address [1]

Level 6
720 Swanston Street
Carlton VIC 3053

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

Grattan Street
Parkville VIC 3010

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

GC Corporation

Address [1]

76-1 Hasunuma-cho
Itabashi-ku
Tokoyo 174-8585

Country [1]

Japan

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Ethics Office 
Melbourne Research Office
Level 5
Alan Gilbert Building
161 Barry Street
University Square
Carlton VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/08/2007

Approval date [1]

23/11/2007

Ethics approval number [1]

0712157

Summary

Brief summary

The aim of this study is to compare the  repair of early tooth decay and penetration of fluoride into the repaired decay after mouthrinsing four times a day for 10 days with a solution of: 1) a tooth creme product containing fluoride and a major component of milk called casein; 2) an oral care product containing fluoride alone.
Subjects will wear a custom-made removable plastic denture-like appliance  that will each hold four pieces of pre-sterilized human tooth enamel containing early decay that has been artificially-created in the laboratory. Subjects will insert their appliance, rinse with 5 mL of one of the two solutions for one minute, spit out the solution, then continue wearing the appliance for a total of 40 minutes. After 10 days' rinsing with one of the solutions, subjects will rest from the study for four days before repeating the exercise with the other solution as before. 
The research team will prepare the solutions by diluting the products in distilled filtered water. Solutions will be freshly prepared for use at the start of each weekday and enough solution for subjects to use on the weekends will be prepared on the Friday beforehand.
Subjects will brush their teeth with a fluoride toothpaste at least one hour before first inserting their appliance that day and rinse their mouths with tap water and their appliance with distilled filtered water immediately prior to inserting their appliance each time. They will also rinse their appliance with distilled filtered water after removing it each time and store their appliance in a humid container at room temperature. Subjects will also be instructed to clean their appliance, avoiding the enamel pieces, with a fluoride-free denture paste once daily. The solutions will be stored at room temperature at all times. Subjects will not eat or drink anything except rinse with their allocated solution when wearing their appliance. Otherwise, subjects will maintain their normal oral hygiene and dietary habits throughout the study.
The hypotheses for this study are: 
1) there will be significantly greater repair of decay after rinsing with the solution containing casein and fluoride than after rinsing with the solution containing fluoride only.
2) penetration of fluoride into the repaired decay will be significantly greater after rinsing with the solution containing casein and fluoride than the solution containing fluoride alone.

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Eric Reynolds AO

Address

School of Dental Science
University of Melbourne
720 Swanston St
Melbourne VIC 3010

Country

Australia

Phone

+61 3 93411547

Fax

+61 3 93411596

e.reynolds@unimelb.edu.au

Contact person for scientific queries

Name

Professor Eric Reynolds AO

Address

School of Dental Science
University of Melbourne
720 Swanston St
Melbourne VIC 3010

Country

Australia

Phone

+61 3 93411547

Fax

+61 3 93411596

e.reynolds@unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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