Comparison of the effectiveness of different brushing methods with the usual method in removing microbial plaque in 11th and 12th grade students
Design
A simple randomized clinical trial with parallel, single-blind, phase 2 block design on 72 participants
Settings and conduct
Schools in Tehran in two stages, at first, all participants brush in their usual way. Then they are divided into 2 equal groups and brush in2 ways that will be taught. Plaque and gingival indexes are measured at each stage.
It is double-blinded that participants do not know the goals and names of the methods But they know the whole study process and the existence of parallel groups. Examiners are also unaware of the purpose of the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria including:
1. Healthy students of the eleventh and twelfth grade
2. No previous receipt of special oral health training
3. At least 6 teeth in each quadrant of the mouth
Exclusion criteria:
1. Existence of oral lesion
2. Having an orthodontic appliance or removable prosthesis
3. Existence of periodontal problems and the presence of envelopes with a depth of 4 mm or more
4. Being a smoker
5. Existence of special disabilities that interfere with the skill of using a toothbrush.
6. History of systemic diseases (diabetes 1 and 2, rheumatic fever, leukemia, etc.)
7. Taking any non-steroidal antibacterial or anti-inflammatory drugs, corticosteroids and, immunosuppressants within 1 month
Before and during the study.
Intervention groups
ّFirstly all participants brush in their usual way. Then they will divide into 2 equal groups and brush in 2 ways that will be taught. Plaque and gingival index will be measured at each stage
Comparison of the effectiveness of different brushing methods with the usual method in removing microbial plaque in 11th and 12th grade students.
Public title
Efficiency of different brushing methods
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy students of the eleventh and twelfth grade
No previous receipt of special oral health training
At least 6 teeth in each quadrant of the mouth
Exclusion criteria:
1. Existence of oral lesion
Students with orthodontic appliance or removable prosthesis
Existence of periodontal problems and the presence of pockets with a depth of 4 mm or more
Being a smoker
Existence of special disabilities that interfere with the skill of using a toothbrush
History of systemic diseases (diabetes 1 and 2, rheumatic fever, leukemia, etc.)
Taking any non-steroidal antibacterial or anti-inflammatory drugs, corticosteroids and immunosuppressants within 1 month Before and during the study
Age
From 12 years old
Gender
Both
Phase
2
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with block design.
Individual randomization unit .
randomization tool also sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blind from the goals of the study and the name of the brushing methods.
Data collectors will be blind from the goals of the study.
The whole study process and the existence of parallel groups will be explained to the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry - Tehran University of Medical Sciences
Street address
Tehran dental school, North Kargar Ave, enghelab Eslami Sqr,
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.008
Health conditions studied
1
Description of health condition studied
Efficiency of different brushing methods compared to the usual method of each person .
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plaque index
Timepoint
At the beginning of the study (after 48 hours without brushing) . after brushing in the usual way, after 48 hours of not brushing, after brushing in the trained methods.
Method of measurement
With disclosing agent and examination intraoral mirror
2
Description
Gingival index
Timepoint
At the beginning of the study (after 48 hours without brushing) . after brushing in the usual way, after 48 hours of not brushing, after brushing in the trained methods.
Method of measurement
Clinical examination with intraoral mirror and periodontal probe.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Initially,all volunteers will not brush their teeth for next 48 hours. Then they will brush with their usual brushing method twice a day and the plaque index and gingival index will record.
Category
Other
2
Description
Category
Other
3
Description
Intervention group : Do not brushing for next 48 hours. Plaque index and gingival index will be recorded. then they will brush twice in 24 hours using Modified Bass method. and after that, plaque index and gingival index will record.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikan Boys high school
Full name of responsible person
Mohsen Kashani Vahid
Street address
No. 21, Corner of Yasman Alley, At the beginning of Chenaran St, Shahid Fayyazi (Fereshteh) St, Above Parkway intersection, Hazrat Vali-e-Asr St,
City
Tehran
Province
Tehran
Postal code
1964959563
Phone
+98 21 2200 9630
Email
Nikan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirali Sohrabpour
Street address
Shafa building, Italy St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8241 5000
Email
aasohrabpour@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Tehran University of Medical Sciences
Full name of responsible person
Farzad Emamverdi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 1 , 39th Vozara Ave , Beheshti Ave , Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8888 5611
Fax
Email
farzad.emamverdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Reza Yazdani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran Dental School , North Kargar St , Enghelab Eslami Square
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4500
Email
ryazdani@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Emamverdi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Tehran Dental School, North Kargar Ave, Enghelab Eslami Sqr,
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4500
Fax
Email
farzad.emamverdi@yahoo.com
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