The purpose of this study is to compare the anti-plaque property of miswak stick in comparison with classic toothbrush.
Design
Single-blind cross over randomized clinical trial. Sealed envelopes were used to randomize 16 volunteers (8 volunteers in each group).
Settings and conduct
Faculty of dentistry of Tehran university of medical sciences (TUMS) was considered as the study site. Both groups will be taught how to brush their teeth using the Rolling method. The first group will use miswak stick and the second group will use classic toothbrush for one week twice a day. After a week as wash out period, the volunteers will be transferred between groups. That is, the first group will use classic toothbrush and the second group will use miswak stick. On the 1st, 7th, 14th, and 21st days, an examination is performed to record the indicators of O'leary plaque and bleeding on probing (BOP).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 to 35 years, presence of at least 20 teeth in occlusion, depth of the sulcus less than 3 mm, O'leary plaque index between 20 and 35 percent
Exclusion criteria: systemic diseases, gingivitis and periodontitis, orthodontic appliance, restoration larger than usual (Overhang) or undesirable prostheses (Overcontour), motion and skill disorder, narcotic addiction, smoking, abnormal occlusion
Intervention groups
First group: using miswak stick
Second group: using classic toothbrush
Main outcome variables
O'leary plaque index
Bleeding on probing (BOP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058179N1
Registration date:2023-06-15, 1402/03/25
Registration timing:prospective
Last update:2023-06-15, 1402/03/25
Update count:0
Registration date
2023-06-15, 1402/03/25
Registrant information
Name
Atiyeh Khorram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4163
Email address
a.khoram92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of plaque index and bleeding on probing scores in patient who use classic toothbrush and Salvadorapersica stick
Public title
Comparison between classic toothbrush and miswak stick
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 35 years
Presence of at least 20 teeth in occlusion
Depth of the sulcus less than 3 mm
O'leary plaque index between 20 and 35 percent
Exclusion criteria:
Systemic diseases
Gingivitis and periodontitis
Orthodontic appliance
Restoration larger than usual (Overhang) or undesirable prostheses (Overcontour)
Motion and skill disorder
Narcotic addiction
Smoking
Abnormal occlusion
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization unit: individual
Randomization tool: Sealed envelopes
There is not allocation concealment.
Sealed envelopes were prepared according to the number of people participating in the study, half of the envelopes were related to the A group and half were related to the B group. One of the envelopes will be randomly assigned to each participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded (clinical assessor has been blinded.)
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University Of Medical Sciences
Street address
Keshavarz Boulevard - Quds St. intersection
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-01-22, 1401/11/02
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.134
Health conditions studied
1
Description of health condition studied
Dental plaque
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Bleeding on probing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
O'leary plaque index
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the intervention
Method of measurement
The number of stained dental surfaces, with a disclosing agent (plaque detector tablet), divided by the number of teeth
2
Description
Bleeding on probing (BOP)
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the intervention
Method of measurement
By direct vision with a periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Using a miswak stick in the first stage for one week and then using a classic toothbrush for a week in the second stage (after a one-week wash out stage between stages 1 and 2). At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the intervention, O'leary dental plaque indices and bleeding on probing (BOP) will be measured by the clinical examiner.
Category
Other
2
Description
Intervention group 2: Using a classic toothbrush in the first stage for one week and then using a miswak stick for a week in the second stage (after a one-week wash out stage between stages 1 and 2). At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start of the intervention, O'leary dental plaque indices and bleeding on probing (BOP) will be measured by the clinical examiner.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Tehran university of medical sciences
Full name of responsible person
Dr. Zeinab Kadkhoda
Street address
North Kargar St. - faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8800 4163
Email
zkadkhoda@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Tehran University of Medical Sciences, Quds Junc, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1439845773
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atiyeh Khorram
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 113, Ebrahimi St. North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439845773
Phone
+98 21 8800 4163
Fax
Email
a.khoram92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Kadkhoda
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North Karegar St. - faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8800 4163
Email
zkadkhoda@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atiyeh Khorram
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 113, Ebrahimi St. North Kargar St.
City
Tehran
Province
Tehran
Postal code
1439845773
Phone
+98 21 8800 4163
Fax
Email
a.khoram92@gmail.com
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