Evaluation and comparison of the effects of bleaching gel containing 1% sodium hexametaphosphate on color stability and dental sensitivity during and after bleaching: a randomized, triangular blinded clinical trial study.
After obtaining informed consent from the applicants participating in the study, and after cleaning the teeth with pumice powder, the primary color of the anterior teeth is evaluated by a spectrophotometer at a specific time and place. The method of bleaching substances in this study is split mouth and the selection of the mid-jaw treated as a randomized control or test, so that each patient randomly chooses a type of treatment for his half-jaw. The rendering of patients is done by another person who is not involved in the study, type of treatment, and control and testing groups.
Participants/Inclusion and exclusion criteria
Patients need to be treated for bleaching for which they are given this treatment so that the teeth that are needed to bleach for them are free of decay or repairs.
Patients should be between 18 and 40 years old.
Intervention groups
Intervention group: Randomly selected half maxilla and bleaching gel containing 37/5% hydrogen peroxide in combination with 1% sodium hexametaphosphate. Control group: Randomly selected half maxilla and bleaching gel containing 37/5% hydrogen peroxide.
Main outcome variables
Dental sensitivity reported by patients before and during and immediately after the treatment, one month and three months after the treatment of office bleaching of the teeth and the degree of color stability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040294N1
Registration date:2019-10-26, 1398/08/04
Registration timing:retrospective
Last update:2019-10-26, 1398/08/04
Update count:0
Registration date
2019-10-26, 1398/08/04
Registrant information
Name
Mehrzad Khorshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 1306
Email address
Khorshidm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effects of bleaching gel containing 1% sodium hexametaphosphate on color stability and dental sensitivity during and after bleaching: a randomized, triangular blinded clinical trial study.
Public title
Evaluation and comparison of the effects of bleaching gel containing 1% sodium hexametaphosphate on color stability and dental sensitivity during and after bleaching: a randomized, triangular blinded clinical trial study.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients need to be treated for bleaching for which they are given this treatment so that the teeth that are needed to bleach for them are free of decay or repairs.
Patients in favorable general and oral health conditions.
Patients without dental sensitivity by touch and thermal stimuli.
Exclusion criteria:
Patients with a history of disease or long-term use of the drug.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization with sealed envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is performed on the same subjects, but in different parts of the body, they have two or more interventions, so that by random selection of an envelope, which half-jaw is the control and the other half is intervention.
The data analyst is also a third party.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Mashhad University of Medical Science, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9185754934
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.082
Health conditions studied
1
Description of health condition studied
Bad teeth color
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tooth color by spectrophotometer and tooth sensitivity by VAS system
Timepoint
Before and after treatment, immediately after treatment and 24 hours after treatment, one week after treatment, one month after treatment and 3 months after treatment.
Method of measurement
Tooth color by spectrophotometer and tooth sensitivity by VAS system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before initiation of study, a retractor will be used to retract the lips and cheeks. Then a light-polymerized opaldam (SDI, Australia) will be used to protect the gums and soft tissues. intervention group: the same bleaching gel as the control group with 1% sodium hexametaphosphate will be utilized for 30 minutes on other half of maxilla arch. After completion of the bleaching period and removing the gel and resin dam a complete rinsing will be done.
Category
Treatment - Drugs
2
Description
Control group: control group: the Bleaching gel containing 37.5% hydrogen peroxide Polaoffice+ (SDI, Australia) will be applied for 30 minutes on randomly selected half of maxilla arch.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Science
Full name of responsible person
Mehrzad Khorshid
Street address
Mashhad University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9185754934
Phone
+98 51 3768 1306
Email
khorshidm921@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Sadat Mohammadipour
Street address
Mashhad University of Medical Science, Azadi square, Vakil-Abad boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mohammadipourh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Sadat Mohammadipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad University of Medical Science, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
mohammadipourh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Sadat Mohammadipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad University of Medical Science, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-984
Phone
+98 51 3882 9501
Email
mohammadipourh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehrzad Khorshid
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Azadi square, Mashhad university of medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
9185754934
Phone
+98 51 3768 1306
Fax
Email
mehrzad.khorshid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of this study related to the main outcome at the end of the study released in a published article.
When the data will become available and for how long
About one year
To whom data/document is available
Anybody who needs the information.
Under which criteria data/document could be used
There was no specific conditions.
From where data/document is obtainable
By sending an email to Dr Hamideh Sadat Mohammadipour
What processes are involved for a request to access data/document
Immediately after receiving the email, it will response.