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Trial registered on ANZCTR


Registration number
ACTRN12610001050044
Ethics application status
Not yet submitted
Date submitted
20/09/2010
Date registered
30/11/2010
Date last updated
30/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Potential of Functionalised tri-Calcium Phosphate in the relief of dentine hypersensitivity
Scientific title
The capacity of fTPC [Functionalised tri-Calcium Phosphate] to enhance the ability of fluoride in relieving dentine hypersensitivity
Secondary ID [1] 252722 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dentine hypersensitivity 258212 0
Condition category
Condition code
Oral and Gastrointestinal 258395 258395 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 agent being investigated in this study (Clinpro Tooth Creme) utilises a funtionalised tri-calcium phosphate ingredient not currently available in any current dentine desensitizing agents. It is hypothesised that this ingredient enhances the absorption of fluoride, calcium and phosphate into the tooth allowing greater remineralization to occur. In the context of hypersensitvity this increased remineralization will aid in blocking the hydrodynamic pain mechanism

Invetervention Group 1:

Apply a pea-sized amount of Clinpro Tooth Creme to a soft-bristled toothbrush and brush teeth for 2 minutes twice daily.
After brushing, adults should expectorate.

Intervention Group 2:

Twice daily brushing with a pea-size amount of Tooth Creme AND a directed topical application of Tooth Creme onto sensitive teeth before sleeping without rinsing.

The product shall be used for 6 weeks. A 6 week period has been shown as providing sufficient time to allow maximum benefit of a desensitizing product (Ricarte, 2008)
Intervention code [1] 257228 0
Treatment: Drugs
Comparator / control treatment
Negative control - a standard toothpaste, with no active desensitisating ingredients (1000ppm fluoride)- Colgate cavity Protection

To be used twice daily for 6 weeks.

Positive control/Comparator - Currently available dentine desensitizing agent, prespecified by the Investigator - Sensodyne Total Care Paste is to be used.

To be used as a toothpaste to brush teeth twice daily, for a duration of 6 weeks. A 6 week period has been shown as providing sufficient time to allow maximum benefit of a desensitizing product (Ricarte, 2008)
Control group
Active

Outcomes
Primary outcome [1] 259234 0
Sensitivity testing using a 10 point visual analogue pain scale.

The clinical measures of sensitivity will comprise of the patient being exposed to three different stimuli directly onto sensitive teeth.
a) Cold air triplex blast (thermal + evaporative) for 1 second
b) Sucrose soaked cotton pellet (chemical + osmotic) for 3-5 seconds
c) Lemon juice soaked cotton pellet (chemical + osmotic) for 3-5 seconds
d) Direct probing (tactile) for 3-5 seconds.
Timepoint [1] 259234 0
initial assessment (baseline), then at 4, 6 and 10 weeks
Secondary outcome [1] 265639 0
Nil
Timepoint [1] 265639 0
Nil

Eligibility
Key inclusion criteria
1. 18-70 years old
2. In good general health
3. At least 2 teeth with exposed root surface that are responsive on probing with a periodontal probe or a 1 second air blast from triplex . These teeth will not exhibit diagnosed caries, defective restorations or signs of fracture on initial assessment. Also these teeth will not have had dental restorations, periodontal surgery or orthodontics that has resulted in post operative pain in the immediate past 3 months.
4. Patient must read and sign the consent form
5. Patient must be capable and willing to brush teeth at least 2 times a day for 2 min
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria is as follows:
- Using desensitizing therapy regulary in the 3 months prior to selection
- Regular medical treatment involving anti inflammatory and analgesic use
- Pregnant or nursing
- Allergies to any components used in products involved in testing
- Eating disorders
- System diseases causing dental sensitivity
- Excessive dietary exposure to acids
- Inability to read the oral hygiene instructions given

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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257676 0
Commercial sector/Industry
Name [1] 257676 0
3M ESPE Dental Products, a division of 3M Company
Country [1] 257676 0
United States of America
Primary sponsor type
Individual
Name
Dr. Steven Naoum
Address
Faculty of Dentistry
THE UNIVERSITY OF SYDNEY
Westmead Centre For Oral Health
Level 1, Room 1312
Westmead Hospital, Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 256892 0
None
Name [1] 256892 0
Address [1] 256892 0
Country [1] 256892 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259710 0
Ethics committee address [1] 259710 0
Ethics committee country [1] 259710 0
Date submitted for ethics approval [1] 259710 0
26/10/2010
Approval date [1] 259710 0
Ethics approval number [1] 259710 0

Summary
Brief summary
Introduction

The currently accepted definition of dentine hypersensitivity states that ‘Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentin in response to stimuli, typically thermal, evaporative, tactile, osmotic, or chemical, and which cannot be ascribed to any other form of dental defect or disease.’

The hydrodynamic theory is the most widely demonstrated and accepted pathophysiological theory of dentine hypersensitivity. The theorem proposes that dentine hypersensitivity is a result of movement of fluid within the dentine tubules. Most pain-producing stimuli cause movement of dentinal tubule fluid, the most common being cold and evaporative stimuli. This results in a pressure change across the dentin which activates intra-dental nociceptive nerve fibers, via a mechanoreceptor response, to cause pain.

Currently available dentine desensitisers can be divided into two categories by their modus operandi: one is to interrupt the neural response to pain stimuli; the other is to occlude open tubules to block the hydrodynamic mechanism.

Clinpro Tooth Creme is a white paste that contains 950 ppm fluoride ion (similar to regular toothpaste) and a functionalised tri-calcium phosphate ingredient

Aims

1) Investigate the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity
2) Assess the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity in comparison to an alternative desensitising agent
3) Compare the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity when applied topically and with brushing vs application during brushing only
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31660 0
Address 31660 0
Country 31660 0
Phone 31660 0
Fax 31660 0
Email 31660 0
Contact person for public queries
Name 14907 0
Dr. Steven Naoum
Address 14907 0
35A Denison Road
Lewisham, 2049
NSW
Country 14907 0
Australia
Phone 14907 0
+61 2 98455822
Fax 14907 0
+61 2 96334759
Email 14907 0
[email protected]
Contact person for scientific queries
Name 5835 0
Dr. Steven Naoum
Address 5835 0
35A Denison Road
Lewisham, 2049
NSW
Country 5835 0
Australia
Phone 5835 0
+61 2 98455822
Fax 5835 0
+61 2 96334759
Email 5835 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.