Objective: The purpose of this study was Comparing clinical efficacy of Hygen toothbrushes with and without battery in plaque removing from the teeth surface of students
Design: In this clinical study, 40 students who are volunteers will be selected. Patients will be randomly divided into two groups with simple method, one group will be given toothbrushes with battery and the other group will be given toothbrushes without battery. Before brushing plaque will be measured and recorded. patients will brush a week then plaque will be measured and recorded and then the first toothbrush will be taken and second toothbrush will be given; the process will be repeated. In this regard, the biological samples will be taken before and after brushing.
participants including major eligibility criteria:they are systemically healthy, are not smoker and pregnant (in women), Do not have orthodontic appliances, extensive restoration, or any device with brush interference , do not need to surgery in the oral cavity and they have the motivation and skills to participate in the study
intervention: using of ionic toothbrushes with battery
main outcome: removing plaque from the teeth surface
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212174877N15
Registration date:2013-07-05, 1392/04/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare clinical efficacy of Hygen toothbrushes with and without battery in plaque removing from the teeth surface of students
Public title
Compare clinical efficacy of Hygen toothbrushes in plaque removing from the teeth surface
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: systemically healthy, are not smoker and pregnant (in women). Do not have orthodontic appliances, extensive restoration, or any device with brush interference . do not need to surgery in the oral cavity and they have motivation and skills to participate in the study
Age
From 20 years old to 26 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Research vice chancellor, Dental School, Isfahan University of Medical Sciences, Hezarjerib avenue, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2011-01-21, 1389/11/01
Ethics committee reference number
389464
Health conditions studied
1
Description of health condition studied
Chronic gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
2
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
amount of microbial plaque
Timepoint
( before and 2 weeks after brushing)before and 2 weeks after intervention
Method of measurement
Microbial plaque measurement will be done before and after brushing with O'Leary index.
Secondary outcomes
1
Description
Detection colony forming units
Timepoint
2 weeks
Method of measurement
Microbial assessment will be done for detection of colony forming units [CFU] from the plaque samples which will collected with paper cone both before brushing and after brushing. The samples will be suspended in BPS and in order to transfer to culture
Intervention groups
1
Description
Intervention1: using of ionic toothbrush with battery(hygen ionic, Hukuba Dental Corporation, Japan), twice a day, with bass technique
Category
Prevention
2
Description
Intervention 2: using ionic toothbrush without battery(hygen ionic, Hukuba Dental Corporation, Japan), twice a day, with bass technique
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences- School of Dentistry
Full name of responsible person
Dr Jaber Yaghini
Street address
Department of Periodontology, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib avenue,Isfahan,Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
School of Dentistry, Isfahan University of Medical Science , Hezarjerib Avenue, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences - School of Dentistry
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontology, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib avenue,Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 93050508
Fax
Email
mozhgan.izadi.1165@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Periodontology, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Periodontology, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 913 305 0508
Fax
Email
mozhgan.izadi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)