The effect of using toothbrush stick with toothbrush comparing with toothbrush on controlling plaque index of dental students, A randomized clinical trial (RCT)
determining the effect of using toothbrush stick on plaque control
Design
with control group, with parallel groups,Single blinding, 60 participants, Randomized web
Settings and conduct
Sixty dental students of Babol University of Medical Sciences (30 males and 30 females) will be selected using simple random sampling method. Participants will sign a consent form before participating to this study. The duration of the study will be three weeks. Participants will be examined the day before intervention, and on the 7th, 14th and 21st days after the intervention. Plaque index and gingival index will be recorded using olary and loe and silness methods respectively. The study will be single blind. A person other than the examiner will do a web-based randomization at https://Randomization.com. He will distribute toothbrush and toothbrush stick in to the intervention group (toothbrush stick with toothbrush) and the control group (toothbrush only).
Participants/Inclusion and exclusion criteria
inclusion criteria:Student of Babol Dental School; Age range 18-25 years
plaque index range 20-30%
No inclusion criteria:orthodontic appliance; Dental prosthesis; Extensive restoration
Intervention groups
The intervention group will use a toothbrush stick every morning after breakfast and toothbrush and toothpaste every night befor going to bed; The control group will use only toothbrush and toothpaste every morning after breakfast and every night befor going to bed.
Main outcome variables
Plaque index; Gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048464N1
Registration date:2020-10-01, 1399/07/10
Registration timing:retrospective
Last update:2020-10-01, 1399/07/10
Update count:0
Registration date
2020-10-01, 1399/07/10
Registrant information
Name
Mohammad Mehdi Naghibi Sistani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 5985
Email address
m.naghibi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-04-24, 1399/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using toothbrush stick with toothbrush comparing with toothbrush on controlling plaque index of dental students, A randomized clinical trial (RCT)
Public title
the effect of using toothbrush stick on controlling gingival indices in comparison with toothbrush
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Student of babol dental school
Age range 18-25 years
Plaque index range 20-30%
Web Randomization on site https://Randomization.com, six block method
A colleague other than the researcher does the randomization and keep the randomization list and give participants a toothbrush and toothpaste or toothbrush stick
Blinding (investigator's opinion)
Single blinded
Blinding description
Research Fellow,Impact Assessor,Data Analyzer
A colleague other than the researcher give participants a toothbrush and toothpaste or toothbrush stick
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol Univessity of Medical Sciences
Street address
Babol University of Medical Sciences. Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
۴۷۷۴۵-۴۷۱۷۶
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.MUBABOL.REC.1399.219
Health conditions studied
1
Description of health condition studied
Plaque index
ICD-10 code
-
ICD-10 code description
-
2
Description of health condition studied
Gingival index
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Percent of tooth surface with plaque (plaque index)
Timepoint
Measuring plaque index at the beginning of the study, on days 7, 14 and 21 after using toothbrush stick
Method of measurement
calculating colored tooth surface by Olary method
Secondary outcomes
1
Description
Gingival index
Timepoint
At the beginning of the study, on days 7, 14 and 21 after the start of the study
Method of measurement
With Williams probe under unit light and dental mirror by loe and silness method
Intervention groups
1
Description
Intervention group: They will use toothbrush stick every morning after breakfast and toothbrush and toothpaste using Modify Bass method every night before going to bed.
Category
Prevention
2
Description
Control group: Every day after breakfast and before bed, they will use only toothbrushes and toothpaste using the Modify Bass method.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Naghibi Sistani
Street address
Babol Dental School.Palestine Square
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۳۶۳۳
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
m.naghibi@mubabol.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Naghibi Sistani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Babol Dental School, Palestine Square
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
m.naghibi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Naghibi Sistani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Babol Dental School, Palestine Square
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۳۶۳۳
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
m.naghibi@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Naghibi Sistani
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Ganj Afruz street, Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
47176-43633
Phone
+98 11 3222 5985
Fax
Email
m.naghibi@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD