comparison effect of anti sensitivity toothpaste with anti sensitivity gel and mouthwash in resolve of the root dentin hypersensitivity after scaling and root planning
The puepose of the study is comparison effect of anti sensitivity toothpaste with anti sensitivity gel and mouthwash in resolve of the root dentin hypersensitivity after scaling and root planning
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment.
we have four groups in our study ,contol؛ toothpaste ؛ mouthwash ؛gel
Settings and conduct
location : department of periodontics ,tabriz University of medical sciences ,dental school
the patiens will be collected from the referrral patiens from private offices and department from 2019-5 up to 2019-6
Participants/Inclusion and exclusion criteria
inclusion criteria:
moderate periodontitis؛
the patient shuold have at least 10 functional teeth (except third molars)؛
no systemic disease؛
Full mouth score plaque more than 25 %؛
no antibiotic use in the past 3 months؛
no tooth hypersensitivity؛
exclusion criteria :
unwilling to be engaged in the study؛
pregnancy and breast feeding؛
use of drug ,alcohol,smoking؛
the lack of inclusion criteria؛
the patients that is at the baseline of the hypersensitivity
Intervention groups
gruop 1-phase one plus anti-sensitive tooth paste
group 2-phase one plus anti-sensitive mouthwash
group 3-phase one plus anti-sensitive gel
group 4-control group
Main outcome variables
BOP(bleeding on probing )
PD(probing depth)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120702010155N5
Registration date:2019-08-18, 1398/05/27
Registration timing:retrospective
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Mohammad Taghi Chitsazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
chitsazm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison effect of anti sensitivity toothpaste with anti sensitivity gel and mouthwash in resolve of the root dentin hypersensitivity after scaling and root planning
Public title
comparison effect of anti sensitivity toothpaste with anti sensitivity gel and mouthwash in resolve of the teeth hypersensitivity after cleaning by dentist
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-moderate periodontities
the patient shuold have at least 10 functional teeth (except third molars)
no systemic disease
Full mouth score plaque more than 25 %
no antibiotic use in the past 3 months
no tooth hypersensitivity
Exclusion criteria:
unwilling to be engaged in the study
pregnancy and breast feeding
use of drug ,alcohol,smoking
the lack of inclusion criteria
the patients that is at the baseline of the hypersensitivity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
randomization by the use of "http://www.randomizer.org in three groups ,each group containing 20 patient
in tooth paste group one SENSODYNE toothpaste tube will be delivered to the patient ,in GELL group one SENIKIN gel tube will be delivered to the patient and in test group VAS test will be administered.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
2181455618
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.TBZMED.REC.1398.300
Health conditions studied
1
Description of health condition studied
periodontities
ICD-10 code
K05.4
ICD-10 code description
Periodontosis
Primary outcomes
1
Description
BOP
Timepoint
before the beginning the study - 2 weeks later -4 weeks later
Method of measurement
CHECK LIST
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mouthwash.in mouthwash group one SENSIKIN mouthwash bottle will be delivered to the patient ,the patient will be asked to use mouthwash for half an hour and avoid eating and drinking 30 minutes thereafter after one week VAS test will be administered.
Category
Treatment - Other
2
Description
Intervention group: tooth paste.in tooth paste group one SENSODYNE toothpaste tube will be delivered to the patient ,the patient will be asked to brush twice a day and avoid eating and drinking 30 minutes thereafter after one week VAS test will be administered.
Category
Treatment - Other
3
Description
intervention group: gel.in gel group one SENSODYNE toothpaste tube will be delivered to the patient ,the patient will be asked to use gel twice a day and avoid eating and drinking 30 minutes thereafter . after one week VAS test will be administered.
Category
Treatment - Other
4
Description
Control group: no toothpaste -no mouthwash-no gel .after one week the patients will be asked about sensitivity and VAS test will be administered.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentisty faculty Tabriz university of medical sciences
Full name of responsible person
mohammad tagi chitsazi
Street address
Daneshgah street -Dentisty faculty Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
۰۴۱۳۳۳۶۳۲۹۹
Phone
+98 41 3336 3299
Fax
+98 41 3336 3299
Email
chitsazm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Daneshgah street -Dentisty faculty Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
۰۴۱۳۳۳۶۳۲۹۹
Phone
+98 41 3335 7310
Fax
+98 41 3336 3299
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
محمد تقی چیت سازی
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah street -Dentisty faculty Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
۰۴۱۳۳۳۶۳۲۹۹
Phone
+98 41 3336 3299
Email
chitsazm@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mohammad tagi chitsazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah street -Dentisty faculty Tabriz university of medical sciences
City
tabriz
Province
East Azarbaijan
Postal code
۰۴۱۳۳۳۶۳۲۹۹
Phone
+98 41 3336 3299
Email
chitsazm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
The Islamic Republic of Iran, East Azerbaijan, Tabriz, University Circle, University Avenue, Tabriz University of Medical Sciences, School of Dentistry, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
mtchitsazi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available