The aim of research: clinical study of changing the bleaching agent's pH for improving the color of discolored teeth.
Inclusion criteria: dark teeth, absence of cracks and decay.
Exclusion criteria: dental fluorosis.
The study population and sample size: This study performes on 36 patients who voluntarily for bleaching.
Intervention study and time: Patients divided randomly into three groups during 1 year. Patients receive one visit office bleaching 45 minutes treatment with 35% hydrogen peroxide at pH 8 and 10 and in the control group, pH is 6.4.
The primary outcome: tooth whitening and sensitivity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111030813N1
Registration date:2017-01-15, 1395/10/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-15, 1395/10/26
Registrant information
Name
Sahar Zeraatkar Davani
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 7792
Email address
drzeraatkar.s@gmail.com
Recruitment status
Recruitment complete
Funding source
YAZD University of Medical Sciences
Expected recruitment start date
2017-03-19, 1395/12/29
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of pH values of Hydrogen peroxide (35 %) on the ability of whitening teeth in office bleaching technique
Public title
evaluation of tooth whitening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult patients with maxillary anterior teeth with a dark color؛with discoloration caused by tetracycline or other discolorations can be treated with bleaching method؛Dental leave absence؛ lack of wide labial surface of tooth-colored restorations؛ periapical lesion and absence of crowns and tooth sensitivity before treatment؛ lack of exposed roots or missing enamel؛no caries and abrasion and attrition؛ not in pregnancy and lactation.
Exclusion criteria: patient's unwillingness to participate in the study؛ patients with teeth discolorations caused by fluorosis؛ teeth with root canal therapy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Bahonar Square
City
Yazd
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.SSU.REC.1395.172
Health conditions studied
1
Description of health condition studied
Posteruptive colour changes of dental hard tissues
ICD-10 code
K03.7
ICD-10 code description
Posteruptive colour changes of dental hard tissues
Primary outcomes
1
Description
ph
Timepoint
weekly
Method of measurement
Numerical scale
Secondary outcomes
empty
Intervention groups
1
Description
control group:bleaching with ph 6/4
duration of treatment 45 minutes
apply the material on tooth
Category
Treatment - Other
2
Description
intervention group:bleaching with ph 8
duration of treatment 45 minutes
apply the material on tooth
Category
Treatment - Other
3
Description
intervention group:bleaching with ph 10
duration of treatment 45 minutes
apply the material on tooth
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd University of Dentistry
Full name of responsible person
Sahar Zeraatkar Davani
Street address
Dahe Fajr Boulevard
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hasan Mozaffari
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
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
Yazd University of Dentistry
Full name of responsible person
Sahar Zeraatkar
Position
Resident of Operative Dentistry
Other areas of specialty/work
Street address
Dahe Fajr Boulevard
City
Yazd
Postal code
Phone
+98 35 3620 4763
Fax
Email
drzeraatkar.s@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Dentistry
Full name of responsible person
Sahar Zeraatkar
Position
Resident of Operative Dentistry
Other areas of specialty/work
Street address
Dahe Fajr Boulevard
City
Yazd
Postal code
Phone
+98 35 3620 4763
Fax
Email
drzeraatkar.s@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Dentistry
Full name of responsible person
Sahar Zeraatkar
Position
Resident of Operative Dentistry
Other areas of specialty/work
Street address
Dahe Fajr Boulevard
City
Yazd
Postal code
Phone
+98 35 3620 4763
Fax
Email
drzeraatkar.s@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)