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Trial registered on ANZCTR
Registration number
ACTRN12613001308785
Ethics application status
Approved
Date submitted
23/09/2013
Date registered
25/11/2013
Date last updated
17/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the efficacy of a new instrument for the oral hygiene
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Scientific title
Comparative evaluation of the efficacy of a new instrument "the digital brush" for the oral hygiene in healthy young patients
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Secondary ID [1]
283289
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy patients needing oral hygiene procedures
290172
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Condition category
Condition code
Oral and Gastrointestinal
290559
290559
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: the experimental group receives instructions to perform at "home" oral hygiene twice a day, for 2 weeks, using a toothbrush associated with a new instrument "the digital brush"(consisting on a gauze soaked with chlorhexidine and rolled up on the finger). Oral
hygiene conditions of participants will be evaluted after 2 weeks.
Details: The gauze contains 0,12% chlorhexidine; a) participants rolled up the gauze on the index finger, using rotative mouvements from gums to teeth; the gauze was used only once; b) duration of 30 sec.; c) adherence is improved with 1-instructions made to the participants; 2-explanatory demonstration of its use during the first appointment; 3-daily patient diary.
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Intervention code [1]
288014
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Treatment: Devices
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Comparator / control treatment
Control Arm: the control group receives instructions to perform at "home" oral hygiene twice a day, using a toothbrush associated with a chlorhexidine mouthwash (used after toothbrushing for rinsing the mouth). Oral hygiene conditions of participants will be evaluted after 2 weeks.
Details: 1.Participants of the control group use 5ml of 0,12% chlorhexidine mouthrinse; 2) for 20 sec.
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Control group
Active
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Outcomes
Primary outcome [1]
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Participant's plaque index evaluation, using full mouth plaque score (according to Guerrero et al. J Clin Periodontol 2005)
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Assessment method [1]
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Timepoint [1]
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baseline and after 2 weeks
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Secondary outcome [1]
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Participant's bleeding index, using full mouth bleeding score (according to Guerrero et al. J Clin Periodontol 2005)
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Assessment method [1]
304844
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Timepoint [1]
304844
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baseline and after 2 weeks
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Secondary outcome [2]
304852
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Lobene modified index (evaluation of extrinsic stains, according to Moran et al. Int J Dent Hygiene 2005)
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Assessment method [2]
304852
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Timepoint [2]
304852
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baseline and 2 weeks
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Secondary outcome [3]
304853
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Subjective appreciation (using the VAS Visual Analogue Score from 0 to 10)
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Assessment method [3]
304853
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Timepoint [3]
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2 weeks
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Eligibility
Key inclusion criteria
Enrollment of the participants will be performed at the Polytechnic University of Marche (Ancona, Italy), including healthy subjects aging between 18 and 35, good physical health, smokers and not
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Important periodontal disease; periodontal surgery within the previous 6 months; ongoing treatment with antibiotics and/or anti-inflammatory drugs; pregnancy or lactation; chronic systemic disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The main outcome was the difference across groups between the mean change in plaque score from baseline to the end of the follow-up. According to a previous study (Overholser et al., J Clin Periodontol 1990), the expected reduction was 2.5+- 1, in
both groups. However,the expected mean score at the end of the follow-up will be 0.5+-0.6 for mouthrinse group and 1.0+-0.6 for experimental gauze group. Using an unpaired t-test,
and assuming an a-error alpha of 0.05, and an expected withdrawal/dropout rate of 5%, a minimum of 26 subjects per
group were requested to achieve an 80% statistical power.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
6/05/2013
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Actual
6/05/2013
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Date of last participant enrolment
Anticipated
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Actual
11/10/2013
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Date of last data collection
Anticipated
20/07/2018
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Actual
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Sample size
Target
60
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Accrual to date
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Final
58
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Recruitment outside Australia
Country [1]
5439
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Italy
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State/province [1]
5439
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Ancona
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Funding & Sponsors
Funding source category [1]
288029
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University
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Name [1]
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University " Politecnica delle Marche", Dipartimento di Scienze Cliniche Specialistiche ed Odontostomatologiche
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Address [1]
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Via Tronto 10, 60026 Torrette di Ancona (AN)
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Country [1]
288029
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Italy
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Primary sponsor type
University
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Name
Polytechnic University of Marche, Section of Stomatology
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Address
Via Tronto 10/A, Torrette di Ancona 60026
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Country
Italy
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Secondary sponsor category [1]
286746
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None
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Name [1]
286746
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Address [1]
286746
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Country [1]
286746
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Other collaborator category [1]
277635
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Commercial sector/Industry
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Name [1]
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Micerium S.p. A.
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Address [1]
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Via Marconi 83, 16036 Avegno (GE)
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Country [1]
277635
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Italy
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289950
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Comitato Etico Azienda Ospedaliero-Universitaria Ospedali Riuniti
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Ethics committee address [1]
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Via Conca, 71-60126 Torrette di Ancona
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Ethics committee country [1]
289950
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Italy
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Date submitted for ethics approval [1]
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30/09/2012
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Approval date [1]
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25/10/2012
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Ethics approval number [1]
289950
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Nil-not provided by our Ethic Committee (internal protocol number is#212497)
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Summary
Brief summary
Using a double-blind, randomized design, the oral hygiene condition of 30 young healthy volunteers using the new instrument "digital brush" associated with toothbrushing will be compared with the oral hygiene condition of 30 participants using mouth rinse associated with toothbrushing.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Angelo Putignano, Professor of Restorative Dentistry
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Address
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Polytechnic University of Marche, Via Tronto 10, 60126 Ancona
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Country
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Italy
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Phone
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+390712206224
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Fax
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Email
43230
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[email protected]
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Contact person for public queries
Name
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Angelo Putignano
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Address
43231
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Polytechnic University of Marche, Via Tronto 10/A, Torrette di Ancona, 60126
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Country
43231
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Italy
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Phone
43231
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+390712206224
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Fax
43231
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Email
43231
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[email protected]
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Contact person for scientific queries
Name
43232
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Giovanna Orsini, Associate Professor of Restorative Dentistry
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Address
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Polytechnic University of Marche, Via Tronto 10/A, 60126 Ancona
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Country
43232
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Italy
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Phone
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+393472483290
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Fax
43232
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Email
43232
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[email protected]
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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.
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