Assessment the effect of the amino acid L-arginine / calcium carbonate based bleaching and tooth sensitivity in teeth whitening procedures in the office:Triple blind random clinical trial inclusion criteria:Inclusion criteria for the study:
patients in need of bleaching for which this therapy is indicated This means that teeth whitening treatment that is required for them to be free of caries or restorations have previously done.Yymaran no complaints from tooth sensitivity in touch and to thermal stimuli
Exclusion criteria:
patients with a history of disease or are taking medicine for a long time,Women who are breastfeeding and pregnancy, patients with conditions such as exposed dentine hypersensitivity and cervical lesions of non-carious teeth
Intervention: Use toothpaste containing amino acid L-arginine / calcium carbonate, during and after treatment in-office teeth whitening.
The intervening period: 8 months
The main outcomes measured: the amount of tooth sensitivity reported by patients before, during, immediately after treatment, and one month after in-office bleaching of vital teeth and bleaching the bleaching agents or other consequences as underlying confounding should be measured:Disorder of tooth sensitivity in understanding the right half or left central incisor to solve the problem, situated between the center line position is not evaluated.Error in evaluation by spectrophotometer color due to surface curvature canine teeth are not evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011832043N1
Registration date:2017-05-30, 1396/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-30, 1396/03/09
Registrant information
Name
Elham Ahsani
Name of organization / entity
School of Dentistry, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 4528
Email address
ahsanie901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, School of Dental Research Council.Governmental
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-03-04, 1395/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of the amino acid L-arginine / calcium carbonate based bleaching and in-office tooth sensitivity in teeth whitening methods
Public title
Assessment the effect of the amino acid L-arginine / calcium carbonate based bleaching and in-office tooth sensitivity in teeth whitening methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients in need of bleaching for which this therapy is indicated This means that teeth whitening treatment that is required for them to be free of caries or restorations have previously done; Patient aged 18 to 40 years; Patients in good general health and oral; No patients complained of tooth sensitivity in touch and to thermal stimuli.
Exclusion criteria: patients with a history of disease or are taking medicine for a long time; People who use orthodontic appliance; patients who have periodontal disease or poor oral hygiene; Women who are breastfeeding and pregnancy; patients with conditions such as exposed dentine hypersensitivity and cervical lesions of non-carious teeth; People who in the past three months have a history of allergy treatments.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Opposite to Mellat Park, Vakil Abad Blvd
City
Mashhad
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.mums.sd.REC.1394.190
Health conditions studied
1
Description of health condition studied
Change the color of dental unpleasant
ICD-10 code
K03.6
ICD-10 code description
Staining of teeth: NOS extrinsic NOS
Primary outcomes
1
Description
The tooth sensitivity
Timepoint
Before treatment, immediately after completion of the work, 24 hours after treatment and one month later
Method of measurement
The patient is sensitive to cold stimuli by benchmark Vlms and spontaneous sensitivity VAS
Secondary outcomes
1
Description
Improved speed color change
Timepoint
Before treatment, immediately after treatment and 24 hours later and one month later
Method of measurement
By photography and visual assessment and spectrophotometry
2
Description
The amount of color change
Timepoint
Before treatment, immediately after treatment and 24 hours later and one month later
Method of measurement
By photography and visual assessment and spectrophotometry
Intervention groups
1
Description
Tooth bleaching gel composition in the experimental group at the office with a paste containing amino acid L-arginine and calcium carbonate will be used during teeth whitening treatment.
Category
Treatment - Drugs
2
Description
In the control group whitening gels alone will be used.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Elham Ahsani
Street address
Opposite to Mellat Park, Vakil Abad Blvd.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,Vice President of Research
Full name of responsible person
Hamide Sadat Mohammadipour
Street address
Opposite to Mellat Park, Vakil Abad Blvd.
City
Mashhad
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,Vice President of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Sadat Mohammadipour
Position
Assistant Professor of Restorative Dentistry
Other areas of specialty/work
Street address
Opposite to Mellat Park, Vakil Abad Blvd.
City
Mashhad
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
Email
Mohammadipourh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamide Sadat Mohammadipour
Position
Specialist of Operative Dentistry
Other areas of specialty/work
Street address
Opposite to Mellat Park, Vakil Abad Blvd.
City
Mashhad
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
+98 51 3882 9500
Email
Mohammadipourh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Ahsani
Position
PhD student of dentistry
Other areas of specialty/work
Street address
Opposite to Mellat Park, Vakil Abad Blvd.
City
Mashhad
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
+98 51 3882 9500
Email
ahsanie901@mums.ac.ir; elhamahsani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)