Determining the effectiveness of two types of whitening toothpastes in inhibiting dental stain
Design
Double-blind clinical trial, with parallel groups, randomized, phase 3 on 40 people
Settings and conduct
This study is a randomized clinical trial on 40 dental students of the Kurdistan University of Medical Sciences. The patients have dental stain . The patients are selected according to the entry and exit criteria. The patients are divided into two groups of 20 people. The first group received whitening toothpaste containing hydrated Silica and whitening toothpaste containing alphapinene were given to the second group and the patients were asked to use the toothpaste twice a day in the morning and at night for two minutes each time for 6 weeks. Then a index that includes a Numerical grading is 3-0 used to measure the intensity and location of the stain
Participants/Inclusion and exclusion criteria
Having at least 4 anterior teeth and premolars with stain and without restoration, caries and removable orthodontic appliance or removable and fixed prosthesis
Plaque index below 20% and absence of periodontitis
Intervention groups
patients are randomly divided in two groups.(A is whitening toothpaste containing hydrated silica and B is whitening toothpaste containing alphapinene)
Main outcome variables
dental stain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220726055559N4
Registration date:2023-11-12, 1402/08/21
Registration timing:registered_while_recruiting
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Shabnam Khalifehzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 2260
Email address
shabnam.kh63ii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-08, 1402/08/17
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of two types of whitening toothpastes in inhibiting dental stain
Public title
comparing of two types of whitening toothpaste
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 4 anterior teeth and premolars with stain and without restoration and caries
without orthodontic appliance or removable and fixed prosthesis
Exclusion criteria:
systemic diseases
pregnancy
any restorative treatment and bleaching
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose of block randomization is that equal number of participants enter the intervention and control groups.In this study, randomization is done using Excel software. In this way, at first, the desired blocks (intervention and control group) will be selected with three-digit codes (one English letter and two numbers) for each person, and then random selection will be done using the Rand between command.
The size of each block is 20 people. In this way, one type of whitening toothpaste is assigned to the first block and another type to the second block.
Blinding (investigator's opinion)
Double blinded
Blinding description
whitening toothpaste containing alphapainen and whitening toothpaste containing hydrated silica are named with two letters B&A and will be given to two equal groups of patients. The patients are selected with the minimum entry criteria. There are 20 patients in each group. It will be fully explained to the patients. Written informed consent will be obtained from the patients. The patients will be selected by sampling based on the entry criteria and will be randomly divided into two equal groups. Group A is whitening toothpaste containing hydrated silica and the group B will use toothpaste containing alphapinene. Participants and health personnel will not know the type of toothpaste.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Science
Street address
Pasdaran Ave, Kurdsitan University of Medical Science
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.MUK.REC.1402.113
Health conditions studied
1
Description of health condition studied
dental stain
ICD-10 code
K03.6
ICD-10 code description
Deposits [accretions] on teeth
Primary outcomes
1
Description
dental stain
Timepoint
measurment dental stain at the beginning of the study,after 28 days and 42 days.
Method of measurement
We determine the intensity and location of the stain by using Loben's numerical index, which is 0-3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A They received whitening toothpaste containing silica hydrate. They used the toothpaste on the toothbrush twice a day for 42 days for two minutes each time.
Category
Treatment - Drugs
2
Description
Intervention group: B They receive whitening toothpaste containing alphapinene. They use the toothpaste twice a day for 42 days, for two minutes each time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
Shaghayegh Khoshnama Bahrami
Street address
Kurdistan University of Medical Sciences,Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4645
Email
shaghayegh.khb@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Ave
City
Sanandaj
Province
Kurdistan
Postal code
661713446
Phone
+98 87 3366 4645
Email
Maleki@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Shaghayegh Khoshnama Bahrami
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 91,Bahar building , Baharan
City
Sanandaj
Province
Kurdistan
Postal code
6617738168
Phone
+98 87 3377 1661
Email
shaghayegh.khb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shabnam Khalifehzadeh
Position
Associate Profesosr
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5,Shaghayegh Alley,Lotfi Ave,Shalman Blvs,Sanandaj City
City
Sanandaj
Province
Kurdistan
Postal code
6617975413
Phone
+98 87 3362 2260
Email
Shabnam.kh63ii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shaghayegh Khoshnama Bahrami
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 91,Bahar building ,Baharan
City
Sanandaj
Province
Kurdistan
Postal code
6617738168
Phone
+98 87 3377 1661
Email
shaghayegh.khb@yahoo.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