To assess the effect of brushing with the non-dominant hand versus the dominant hand on gingival index and dental plaque
Design
This is a clinical trial study with a control group using right and left side without blinding and phase 3, in which eligible people will enter the study and their right and left hands will be considered as intervention and control groups.
Settings and conduct
This study will be conducted on 65 students of School of Dentistry in Hamadan city. This study will be done using right and left sides without randomization and without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 35 years;
Student of Hamadan University of Medical Sciences;
Exclusion criteria:
Smoking;
Having an orthodontic appliance or a fixed or mobile prosthesis;
Taking antibiotics or antiseptic mouthwash
Intervention groups
Intervention group:
Brushing with the non-dominant hand using an Oral B medium toothbrush at least once a day for two weeks
Control group:
Brushing with the dominant hand using an Oral B medium toothbrush at least once a day for a week
Main outcome variables
Primary outcome:
The amount of dental plaque, gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N518
Registration date:2024-06-29, 1403/04/09
Registration timing:prospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of brushing with the non-dominant hand versus the dominant hand on gingival index and dental plaque: a clinical trial
Public title
Effect of brushing with the non-dominant hand versus the dominant hand on gingival index and dental plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years;
Student of Hamadan University of Medical Sciences;
Exclusion criteria:
Smoking;
Having an orthodontic appliance or a fixed or mobile prosthesis;
Taking antibiotics or antiseptic mouthwash
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.752
Health conditions studied
1
Description of health condition studied
Gingival index and dental plaque
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
The amount of dental plaque
Timepoint
Before the intervention and one and three weeks after the intervention
Method of measurement
By clinical examination
2
Description
Gingival index
Timepoint
Before the intervention and one and three weeks after the intervention
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Brushing with the non-dominant hand using an Oral B medium toothbrush at least once a day for two weeks
Category
Other
2
Description
Control group: Brushing with the dominant hand using an Oral B medium toothbrush at least once a day for a week
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Dr Mahsa Hadian
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mmahsa.hadian27@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahsa Hadian
Position
Resident of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mmahsa.hadian27@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahsa Hadian
Position
Resident of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mmahsa.hadian27@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available