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Trial registered on ANZCTR


Registration number
ACTRN12612000272897
Ethics application status
Approved
Date submitted
6/03/2012
Date registered
7/03/2012
Date last updated
19/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative evaluation of the efficacy of desensitizing dentifrices
Scientific title
Comparative evaluation of the efficacy of desensitizing dentifrices for the relief of pain in patients suffering of dentine hypersensitivity
Secondary ID [1] 280077 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dentine hypersensitivity in otherwise healthy human volunteers 285988 0
Condition category
Condition code
Oral and Gastrointestinal 286177 286177 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
Arm 1: The experimental group receives a dentifrice -coming in the form of toothpaste- containing nanocrystals of zinc-carbonate-hydroxyapatite, assembled in micro-particles, that have been shown to produce in vitro remineralization of the altered enamel surfaces and to be effective in closing dentinal tubules, thus showing a potential use in desensitising dentifrices (Rimondini et al. 2007, Lee et al. 2008, Roveri et al. 2008). The patients are instructed to brush their teeth for three days, twice a day for at least one minute and not to use any other dentifrice or desensitizing agent.
Intervention code [1] 284402 0
Treatment: Other
Intervention code [2] 284411 0
Treatment: Devices
Comparator / control treatment
2 Control arms are used. Arm2: a group of patients are treated with a dentifrice containing strontium acetate (active control 1), following the same protocol of the experimental group (for three days, twice a day...)
Arm 3: a group of patients are treated with a dentifrice containing 8% arginine and calcium carbonate (active control 2) following the same protocol (for three days, twice a day...).
Control group
Active

Outcomes
Primary outcome [1] 286644 0
Participant's dentin hypersensitivity (DH) was evaluated using Airblast test (primary outcome)
Timepoint [1] 286644 0
Evaluation of DH at baseline and after three days
Secondary outcome [1] 296366 0
DH evaluation by means of Cold water test
Timepoint [1] 296366 0
baseline and after three days
Secondary outcome [2] 296367 0
DH evaluation by means of Tactile test
Timepoint [2] 296367 0
Baseline and after three days
Secondary outcome [3] 296368 0
DH evaluation by means of Subjective test
Timepoint [3] 296368 0
baseline and after three days

Eligibility
Key inclusion criteria
Hypersensitive area on facial surfaces of the teeth: at least two teeth scoring five or more in at least one of the adopted sensitivity tests: Airblast and Cold Water tests; history of tooth hypersensitivity to thermal, mechanical, sweet, or sour stimuli on at least two teeth; good physical health; age between 18 and 70 years; provision of a written informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Chipped teeth, defective restorations, fractured undisplaced cuspids, deep dental caries or large restorations showing pulpal response, deep periodontal pockets, orthodontic appliances, dentures, or bridgework that would interfere with the evaluation of hypersensitivity; periodontal surgery within the previous 6 months; ongoing treatment with antibiotics and/or anti-inflammatory drugs; ongoing treatment for tooth hypersensitivity; pregnancy or lactation; chronic systemic disease

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)
Randomly assigned identification codes of each patient were printed on sealed boxes containing either the test or the active control dentifrices, and each patient had to use only the dentifrices contained in the assigned box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization process was made externally by the statistical unit using a computer-generated random table, and investigators were neither involved in the randomization process nor they were aware of the assigned group in all outcomes evaluations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/10/2011
Actual
27/07/2012
Date of last participant enrolment
Anticipated
Actual
10/12/2012
Date of last data collection
Anticipated
20/07/2018
Actual
Sample size
Target
90
Accrual to date
Final
87
Recruitment outside Australia
Country [1] 4184 0
Italy
State/province [1] 4184 0

Funding & Sponsors
Funding source category [1] 284832 0
University
Name [1] 284832 0
University Politecnica delle Marche, Dipartimento di Scienze Cliniche Specialistiche ed Odontostomatologiche
Country [1] 284832 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
Coswell S.p.A.
Address
Via Gobetti #4, Funo (BO)
Country
Italy
Secondary sponsor category [1] 283710 0
None
Name [1] 283710 0
Address [1] 283710 0
Country [1] 283710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286821 0
Comitato Etico Azienda Ospedaliera-Universitaria Ospedali Riuniti
Ethics committee address [1] 286821 0
Via Conca#71, Torrette di Ancona
Ethics committee country [1] 286821 0
Italy
Date submitted for ethics approval [1] 286821 0
Approval date [1] 286821 0
20/01/2011
Ethics approval number [1] 286821 0

Summary
Brief summary
Using a double-blind, randomized design, the dentifrice based on nano-crystals of carbonate hydroxyapatite is compared with two active control: a dentifrice containing strontium acetate and a dentifrice containing 8% arginine. Participant’s DH was evaluated at baseline and after three days using Airblast, Cold water, Tactile and Subjective tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33868 0
Prof Giovanna Orsini
Address 33868 0
Associate Professor at the Dental School of the Polytechnic University of Marche, Via Tronto 10, 60126, Ancona, Italy
Country 33868 0
Italy
Phone 33868 0
+390712206224
Fax 33868 0
Email 33868 0
[email protected]
Contact person for public queries
Name 17115 0
Angelo Putignano
Address 17115 0
via Tronto 10, 60126, Ancona
Country 17115 0
Italy
Phone 17115 0
+390712206224
Fax 17115 0
Email 17115 0
[email protected]
Contact person for scientific queries
Name 8043 0
Giovanna Orsini
Address 8043 0
via Tronto 10, 60126, Ancona
Country 8043 0
Italy
Phone 8043 0
+393472483290
Fax 8043 0
Email 8043 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
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