Comparing the effectiveness of honey-based toothpaste in reducing dental plaque with common Iranian and foreign toothpastes
Design
Parallel-group trial with the control group, randomized with 117 participants, the block method will be used to assign people to treatment groups randomly.
Settings and conduct
The place of study is Alborz Dental Faculty. After fully explaining the materials used to the patients and informing them, informed consent will be obtained from the patients. Before starting the trial process, the candidates are examined for periodontal problems and dental plaque. Candidates are taught how to brush their teeth and necessary considerations to standardize the study process such as brushing time, etc. Also, all the candidates will be given the same toothbrush.
Participants/Inclusion and exclusion criteria
Participants must have at least 20 teeth and their oral and dental health has been confirmed.
Intervention groups
After recording the plaque index of each person, the 39 people of the first group are given formulated toothpaste and we ask them to use it during the week and come back at the end of the week to re-record the plaque index. In order to register the plaque index, each person is given a disclosing agent and the necessary explanations are given to the candidate regarding the side effects of this substance. Sampling is accessible and easy. The person who evaluates dental plaque is unaware of the groups and the type of intervention they received. This action is repeated for three weeks by the volunteer. So that all people will be checked for dental plaque 3 times and at weekly intervals. All steps are the same for the second and third groups who used Iranian and imported toothpaste, respectively.
Main outcome variables
Changing dental plaque
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230121057172N1
Registration date:2023-02-04, 1401/11/15
Registration timing:prospective
Last update:2023-02-04, 1401/11/15
Update count:0
Registration date
2023-02-04, 1401/11/15
Registrant information
Name
Mohaddeseh Sarzaeem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3256 7175
Email address
m.sarzaeem98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and characterization of honey based toothpaste and comparing its anti-plaque effect with Iran-made and imported toothpaste
Public title
Comparing the effectiveness of honey toothpaste with two common types of toothpaste
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants must have at least 20 teeth
Oral and dental health of the participants must be confirmed.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
117
Randomization (investigator's opinion)
Randomized
Randomization description
To investigate the effect of this toothpaste on dental plaque removal, a randomized clinical trial will be used to determine the plaque score. For this purpose, 117 volunteers are randomly selected among the students and divided into three groups of 39 people. The block method will be used to randomly assign people to treatment groups. After fully explaining the materials used and informing the patients, informed consent will be obtained from the patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Valiasr Blvd.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-12-17, 1401/09/26
Ethics committee reference number
IR.ABZUMS.REC.1401.273
Health conditions studied
1
Description of health condition studied
plaque index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plaque index
Timepoint
0, 7, 14 and 21 days after beginning
Method of measurement
Evaluation of plaque index by disclosing agents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: honey based toothpaste given
Category
Other
2
Description
Intervention group2: Iranian toothpaste given
Category
Other
3
Description
Intervention group3: Foreign Toothpaste given
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Alborz University of Medical Sciences
Full name of responsible person
Mohaddeseh Sarzaeem
Street address
Katoiee zade St., Golshahr
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3353 1614
Email
dentalclinic@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Safarian St., Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mohaddeseh Sarzaeem
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Alborz Faculty of Pharmacy, Valiasr Street, Azimieh
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
m.sarzaeem98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohaddeseh Sarzaeem
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Alborz Faculty of Pharmacy, Valiasr Street, Azimieh
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
m.sarzaeem98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohaddeseh Sarzaeem
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Alborz Faculty of Pharmacy, Valiasr Street, Azimieh
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
m.sarzaeem98@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