The purpose of this clinical trial study is evaluation the effect of using anti sensitivity gel befor home bleaching on tooth sensitivity.
Patients were chosen between women aged 18 – 30 years old who recourse to dentistry college and had not any restoration or caries.
Patient who had history of tooth sensitivity or bleaching treatment, removed from study.
Sample size of each group was determined 15 person, 30 person in total.
Primary tooth color, determined and recorded by devise (easy shade).
Special home tray was made for each person.
Trial gels including: placebo (control group) and anti sensitivity (intervention group) was used in similar tubes (for being double blind) by supervisor.
Patients divided in A or B groups randomly. They should put gels in their mouth with the tray half hour befor using bleaching gel, then wash the tray and their mouth and use carbamide peroxide 16% (FGM) bleach gel, 4 hours in a day, during 14 days.
For evaluation the level of tooth sensitivity, patients will asked to record probable pain level in day 1, 4, 7 and 14 after starting bleaching.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021032484N1
Registration date:2017-04-21, 1396/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Somayeh Somaye
Name of organization / entity
Dentistary
Country
Iran (Islamic Republic of)
Phone
+98 915 341 6206
Email address
somayehtabatabaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of a desensitizing gel used before home bleaching on tooth sensitivity in 18 to 30 years old women: A clinical trial study
Public title
Assessing the effect of a desensitizing gel used before home bleaching on tooth sensitivity in 18 to 30 years old women: A clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Women ages between 18 - 30
; Natural anterior teeth with A2, B2, C2, D2 shade and darker
; At least 24 teeth be present
; Without any anterior restoration
; Good oral hygiene
; Patient consent
exclusion criteria:
Patient with caries.
; Patient with gingivitis or periodontal disease.
; Patient with root exposure teeth.
; Patient with cervical lesions.; People who have orthodontic appliance.
; People who used to have tooth sensitivity to cold and hot or feel sensitivity with puar experiment.
; Using any anti sensitivity ingredients in past 3 months.
; Pregnant and milch women.
; Calculus existent.
;. People who take bleaching treatment before.
11. People who smoke
;. People with has teeth color change influence from fluorosis and tetracycline.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Doctor Hesabi Sq. Zahedan, Iran
City
Zahedan
Postal code
009817699693
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR. ZAUMS. REC.1395.82
Health conditions studied
1
Description of health condition studied
Dental sensitivity after bleaching
ICD-10 code
Z40,Z54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Dental sensitivity
Timepoint
1 to 14 days after start bleaching
Method of measurement
Record on questionnaire by patient
Secondary outcomes
1
Description
Dental pain
Timepoint
1 to 14 days after start bleaching
Method of measurement
Record on questionnaire by patient
Intervention groups
1
Description
Use of desensitizing gel with bleaching gel (Intervention group)
Category
Treatment - Drugs
2
Description
Use of Placebo gel with bleaching gel (Control group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Restorative Dentistry Department, Dental College of Zahedan
Full name of responsible person
Doctor Tabatabaei Somayeh
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Doctor Rafighdoost Hooshang
Street address
Zahedan University of Medical Sciences, Doctor Hesabi Sq. Zahedan, Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan 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
Dental College of Zahedan University of Medical Sciences
Full name of responsible person
Madani Seyed Mohamadreza
Position
Dentistry student
Other areas of specialty/work
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Postal code
9817699693
Phone
+98 54 3341 4004
Fax
Email
mohamadreza.madani.mm@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College of Zahedan University of Medical Sciences
Full name of responsible person
Doctor Tabatabaei Somayeh
Position
Assistant Professor of Restorative dentistary Department, Dental College of Zahedan University of Me
Other areas of specialty/work
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Postal code
9817966993
Phone
+98 54 3341 4004
Fax
Email
somayehtabatabaei@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental College of Zahedan University of Medical Sciences
Full name of responsible person
Doctor Tabatabaei Somayeh
Position
Assistant Professor of Restorative Dentistry Department, Dental College of Zahedan University of Med
Other areas of specialty/work
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 3341 4004
Fax
Email
somayehtabatabaei@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)