Comparing a desensitizing material and a one-step self-etch adhesive on cervical tooth sensitivity after periodontal surgery: A randomized clinical trial
The purpose of this study is to compare the effectiveness a desensitizing material and a one-step self-etch adhesive on cervical tooth sensitivity (CTS) after periodontal surgery. This is a randomized, double-blinded, placebo-controlled and unicentered study. Patients with CTS after periodontal surgery that agree to participate in the study will be chosen. Baseline sensitivity will be recorded with a standard stimuli and Visual Analogue Scale. In each patient three posterior sextants will be randomly allocated to three study groups. Randomization will be performed by choosing a sealed envelope containing the order of treatment protocols. The treatment protocols are: 1- placebo (distilled water), 2- Gluma desensitizer and 3- Clearfil S3 bond. The tooth Sensitivity will be recorded at one day, one week and one month after treatment with the same method as the baseline. The operator and the evaluator are different persons and the evaluator will be blind to the type of treatment. The effectiveness of the different treatments in reducing tooth sensitivity will be compared between groups and between different time intervals.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408176267N2
Registration date:2015-02-25, 1393/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-25, 1393/12/06
Registrant information
Name
Hila Hajizadeh
Name of organization / entity
Mashad Dental School, Department of Restorative Dntistry
Country
Iran (Islamic Republic of)
Phone
+98 51 1765 2219
Email address
hajizadehh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-01, 1393/11/12
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing a desensitizing material and a one-step self-etch adhesive on cervical tooth sensitivity after periodontal surgery: A randomized clinical trial
Public title
Comparing treatment methods for cervical tooth sensitivity after periodontal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with cervical tooth sensitivity after periodontal surgery; Patients agree to participate in the study
Exclusion criteria: Patients receiving professional desensitizing therapy during the previous 3 months; Use of desensitizing toothpaste in the last 6 weeks; Teeth with ICDAS 5 and 6; Root-filled teeth; Crowned teeth; Teeth with cervical restorations interfering with the evaluation; Pregnant or lactating women
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Mashhad University of Medical Sciences
Street address
7th Sanabad, Sadi Square, Mashhad
City
Mashhad
Postal code
91387
Approval date
2014-12-29, 1393/10/08
Ethics committee reference number
930240
Health conditions studied
1
Description of health condition studied
Dentin sensitivity after periodontal surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dentin sensitivity
Timepoint
Immediately before treatment and one day,one week and one month after treatment
Method of measurement
visual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
Using Gluma Desensitizer
Category
Treatment - Drugs
2
Description
Using one-step self-etch adhesive (Clearfil S3 Bond)
Category
Treatment - Drugs
3
Description
Using distilled watter
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hila Hajizadeh
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.hila hajizadeh
Street address
School of Dentistry, Mashhad University of Medical Sciences
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
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
School of Dentistry, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Atefeh Nemati
Position
DDS/DMD
Other areas of specialty/work
Street address
No54, 8th Pastor St., Ahmad Abad Blvd.
City
Mashhad
Postal code
Phone
+98 51 3844 2737
Fax
Email
atefeh.nemati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hila Hajizadeh
Position
Associated professor
Other areas of specialty/work
Street address
Department of Operative Dentistry, School of Dentistry
City
Mashhad
Postal code
Phone
+98 51 3883 2300
Fax
Email
hajizadehh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr.Atefeh Nemati
Position
DDS/DMD
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
atefeh.nemati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)