This randomized single blind parallel clinical trial compares dental hypersensitivity between an experimental group receiving Sensikin gel and a control group receiving Sensodyne toothpaste. A total of 74 participants ( males and females; age range 20 to 50 years) were included in the present study. The volunteers had a history of dental hypersensitivity in at least two teeth with a moderate to severe pain measured at baseline. Participants were randomly assigned into two groups, one receiving a Sensikin gel containing Potassium Nitrate 10% and the other receiving a Sensodyne toothpaste containing Strontium Chloride. dental hypersensitivity measured at the end of first, second, third and forth week of treatment.
General information
Acronym
Sensikin and dental hypersensitivity
IRCT registration information
IRCT registration number:IRCT201202149002N1
Registration date:2012-08-23, 1391/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-23, 1391/06/02
Registrant information
Name
Sara Soheilifar
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 7998
Email address
sara.soheilifar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental faculty of Hamadan University of Medical Sciences
Expected recruitment start date
2012-01-02, 1390/10/12
Expected recruitment end date
2012-04-02, 1391/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Sensikin gel and Sensodyne toothpaste on dental hypersensitivity in patients with dental hypersensitivity.
Public title
Evaluation the effect of Sensikin on dental hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Dental hypersensitivity more than one month; Vital pulp; No use of any other treatments.
Exclusion criteria: Restored teeth; presence of cracks or caries or restored crown
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Opposite of Luna park, Shahid Fahmideh St, Hamadan
City
Hamadan
Postal code
Approval date
2012-01-09, 1390/10/19
Ethics committee reference number
3659/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Dental Hypersensitivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
Dental Hypesensitivity
Timepoint
Befor treatment, first week, second week , third week and forth week of treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
N/A
Timepoint
N/A
Method of measurement
N/A
Intervention groups
1
Description
Sensodyne toothpaste, two times a day for four weeks apply with tooth brush by each participant.
Category
Treatment - Drugs
2
Description
Sensikin gel,1 mg, once a week for four weeks apply to teeth by a dentist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Rozita Jalali
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical faculty of Hamadan University of Medical Sciences
Full name of responsible person
Maryam Asgari
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan University of Medical Sciences, Medical faculty
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical faculty of Hamadan 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 faculty of Hamadan University of Medical Sciences
Full name of responsible person
Rozita Jalali
Position
Student of dentistry
Other areas of specialty/work
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
rozita_jalali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Hamadan University of Medical Sciences
Full name of responsible person
Sara Soheilifar
Position
Assisstant professor
Other areas of specialty/work
Street address
Opposite of Luna park, Shahid Fahmideh St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1835 4017
Fax
Email
sara.soheilifar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)