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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
Scientific title
Comparative evaluation of the efficacy of a new instrument "the digital brush" for the oral hygiene in healthy young patients
Secondary ID [1] 283289 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy patients needing oral hygiene procedures 290172 0
Condition category
Condition code
Oral and Gastrointestinal 290559 290559 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288014 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 290584 0
Participant's plaque index evaluation, using full mouth plaque score (according to Guerrero et al. J Clin Periodontol 2005)
Timepoint [1] 290584 0
baseline and after 2 weeks
Secondary outcome [1] 304844 0
Participant's bleeding index, using full mouth bleeding score (according to Guerrero et al. J Clin Periodontol 2005)
Timepoint [1] 304844 0
baseline and after 2 weeks
Secondary outcome [2] 304852 0
Lobene modified index (evaluation of extrinsic stains, according to Moran et al. Int J Dent Hygiene 2005)
Timepoint [2] 304852 0
baseline and 2 weeks
Secondary outcome [3] 304853 0
Subjective appreciation (using the VAS Visual Analogue Score from 0 to 10)
Timepoint [3] 304853 0
2 weeks

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
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

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?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5439 0
Italy
State/province [1] 5439 0
Ancona

Funding & Sponsors
Funding source category [1] 288029 0
University
Name [1] 288029 0
University " Politecnica delle Marche", Dipartimento di Scienze Cliniche Specialistiche ed Odontostomatologiche
Address [1] 288029 0
Via Tronto 10, 60026 Torrette di Ancona (AN)
Country [1] 288029 0
Italy
Primary sponsor type
University
Name
Polytechnic University of Marche, Section of Stomatology
Address
Via Tronto 10/A, Torrette di Ancona 60026
Country
Italy
Secondary sponsor category [1] 286746 0
None
Name [1] 286746 0
Address [1] 286746 0
Country [1] 286746 0
Other collaborator category [1] 277635 0
Commercial sector/Industry
Name [1] 277635 0
Micerium S.p. A.
Address [1] 277635 0
Via Marconi 83, 16036 Avegno (GE)
Country [1] 277635 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289950 0
Comitato Etico Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ethics committee address [1] 289950 0
Via Conca, 71-60126 Torrette di Ancona
Ethics committee country [1] 289950 0
Italy
Date submitted for ethics approval [1] 289950 0
30/09/2012
Approval date [1] 289950 0
25/10/2012
Ethics approval number [1] 289950 0
Nil-not provided by our Ethic Committee (internal protocol number is#212497)

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43230 0
Prof Angelo Putignano, Professor of Restorative Dentistry
Address 43230 0
Polytechnic University of Marche, Via Tronto 10, 60126 Ancona
Country 43230 0
Italy
Phone 43230 0
+390712206224
Fax 43230 0
Email 43230 0
a.putignano@univpm.it
Contact person for public queries
Name 43231 0
Prof Angelo Putignano
Address 43231 0
Polytechnic University of Marche, Via Tronto 10/A, Torrette di Ancona, 60126
Country 43231 0
Italy
Phone 43231 0
+390712206224
Fax 43231 0
Email 43231 0
a.putignano@univpm.it
Contact person for scientific queries
Name 43232 0
Prof Giovanna Orsini, Associate Professor of Restorative Dentistry
Address 43232 0
Polytechnic University of Marche, Via Tronto 10/A, 60126 Ancona
Country 43232 0
Italy
Phone 43232 0
+393472483290
Fax 43232 0
Email 43232 0
giovorsini@yahoo.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary