Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000317099
Ethics application status
Approved
Date submitted
15/04/2010
Date registered
20/04/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
In vivo plaque calcium phosphate deposition from toothpaste
Scientific title
Pilot trial invovling students at the University of Otago Wellington to determine the level of calcium phosphate mineral deposisted in dental plaque in vivo using a novel plaque mineralising toothpaste as a procedure to protect against dental caries.
Secondary ID [1] 251627 0
TT50-8354(989)
Standing Committee on Therapeutic Trials
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 257145 0
Plaque calcium phosphate mineral dynamics 257146 0
Condition category
Condition code
Oral and Gastrointestinal 257302 257302 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Plaque mineralising toothpaste to be used twice daily (morning and evening) for 4 weeks
Intervention code [1] 256300 0
Treatment: Other
Comparator / control treatment
This trial involves only one treatment arm. Each participant has a 4 week standardisation period using a commercially available toothpaste followed by a 4 week treatment period using the trial toothpaste. All participants will receive the same treatment for 4 weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258211 0
Increased calcium phosphate deposition in plaque assessed by measuring levels of calcium, phosphate, fluoride and protein in the dental plaque.
Timepoint [1] 258211 0
Initial assessment of the primary outcome parameters will be at baseline, then reassessed at week 4 after the 4 week standardisation period, and then again at week 8 following 4 week treatment with the plaque mineralising toothpaste.
Secondary outcome [1] 263860 0
Dental plaque properties: the ability of dental plaque to cause a sucrose-induced pH decrease assessed using a commercially available kit (GC Corp), and microorganism composition analysed in the laboratory using Checkerboard deoxyribonucleic acid (DNA) hybridisation.
Timepoint [1] 263860 0
Initial assessment of secondary outcome parameters will be made at week 0 (baseline), then reassessed at week 4 after the 4 week standardisation period, and then again at week 8 following 4 week treatment with the plaque mineralising toothpaste.
Secondary outcome [2] 263920 0
Saliva properties: pH, buffer capacity, and Streptococcus mutans (S. mutans), assessed using a commercially available kit (GC Corp), and microorganism composition analysed in the laboratory using Checkerboard deoxyribonucleic acid (DNA) hybridisation.
Timepoint [2] 263920 0
Initial assessment at week 0 (baseline), then reassessed at week 4 and at week 8.
Secondary outcome [3] 263921 0
Association of prior oral and general health assessed using questionnaires, plus dental clinical measurements of gingivitis, plaque index, caries history as decayed-missing-filled teeth, and periodontal pocket depth.
Timepoint [3] 263921 0
Initial assessment at week 0 (baseline), then reassessed at week 4 and at week 8.
Secondary outcome [4] 263922 0
Effects of treatment on clinically-assessed gingivitis and calculus formation.
Timepoint [4] 263922 0
Initial assessment at week 0 (baseline), then reassessed at week 4 and at week 8.

Eligibility
Key inclusion criteria
Radiation Therapy and Medical Students at the University of Otago Wellington
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Requirement to treat for periodontal disease or other immediate dental treatment needed.
History of rheumatic heart disease/fever

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2585 0
New Zealand
State/province [1] 2585 0
Wellington

Funding & Sponsors
Funding source category [1] 256800 0
Government body
Name [1] 256800 0
Health Research Council of New Zealand
Country [1] 256800 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
23A Mein Street, Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 256076 0
None
Name [1] 256076 0
Address [1] 256076 0
Country [1] 256076 0
New Zealand
Other collaborator category [1] 1207 0
Hospital
Name [1] 1207 0
Capital and Coast District Health Board
Address [1] 1207 0
Dental and Oral Health Service
Riddiford Street, Newtown
Wellington 6021
Country [1] 1207 0
New Zealand
Other collaborator category [2] 1208 0
University
Name [2] 1208 0
Wellington Institute of Technology
Address [2] 1208 0
Centre for Smart Product
Buick Street, Petone
Wellington 5012
Country [2] 1208 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258822 0
Central Regional Ethics Committee
Ethics committee address [1] 258822 0
Level 2, 1-3 The Terrace
PO Box 5013, Wellington 6011
Ethics committee country [1] 258822 0
New Zealand
Date submitted for ethics approval [1] 258822 0
Approval date [1] 258822 0
01/07/2009
Ethics approval number [1] 258822 0
CEN/08/11/061

Summary
Brief summary
Current approaches to counter dental caries are mainly limited to fluoride treatments which include water fluoridation, fluoridated toothpastes, and professionally applied topical fluoride preparations. The effectiveness of fluoride is limited as almost half the NZ population has an unfluoridated water supply, and toothpaste use is infrequent for many people. New approaches and interventions are needed. The overall aim of our research is to counter caries development by depositing a tooth-like mineral into dental plaque by using a plaque-mineralising toothpaste containing the tooth minerals, calcium and phosphate. The aim is to protect the tooth mineral from acid dissolution, enhance the effectiveness of remineralization induced by fluoride (which will also be supplied in the toothpaste), and modify the plaque microbial composition. This trial is designed to evaluate the efficacy of the plaque mineralising toothpaste by determining the levels of mineral deposited in dental plaque in vivo after its use over a four week period. This study is based on laboratory-based findings in our previous studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31044 0
Address 31044 0
Country 31044 0
Phone 31044 0
Fax 31044 0
Email 31044 0
Contact person for public queries
Name 14291 0
Assoc Prof Chris Sissons
Address 14291 0
University of Otago Wellington
23A Mein Street, Newtown
Wellington 6021
Country 14291 0
New Zealand
Phone 14291 0
+64-4-3855549
Fax 14291 0
+64-4-3855930
Email 14291 0
chris.sissons@otago.ac.nz
Contact person for scientific queries
Name 5219 0
Assoc Prof Chris Sissons
Address 5219 0
University of Otago Wellington
23A Mein Street, Newtown
Wellington 6021
Country 5219 0
New Zealand
Phone 5219 0
+64-4-3855549
Fax 5219 0
+64-4-3855930
Email 5219 0
chris.sissons@otago.ac.nz

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
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