Comparison the effect of superoxidized water with sodium hypochlorite on postoperative pain intensity after single root canall treatment On patients in the endodontics department of the School of Dentistry Islamic azad university in98-99
Design
Clinical trial with control group,with parallel groups,double-blind,randomized,phase2on100patients
Settings and conduct
All steps are performed by the students of the 10th term in Azad Tehran's Dental school؛Blinding has been done as a cover among participants and clinical caregivers
Participants/Inclusion and exclusion criteria
Anterior single canal human teeth
Teeth which without internal or external root absorption
Teeth which without calcification
Teeth which without caries in root
Root curvature of teeth Less than 15 degrees
All samples will have mature apex
All samples will have irreversible pulpaitis
The patient of choice should be without systemic disease
The selected tooth has acute apical periodontitis
All samples will have Sensivity to Percussion
The patient should not use pollen for at least 6 hours before treatment
The patient must be at least 18 years old and at most 65 years old
The patient should not be allergic to lidocaine 1/80,000
Female patients should not be pregnant
The patient should not have Severe periodontal disease
Teeth should not have restoration
Intervention groups
The canal preparation will be done by Step Back technique
The teeth are prepared at least up to file # 30( MAF) and maximum 50
Irrigation volume for each canal:2 ml between each instrument
Over Instrumentation should not occur during root canal treatment
Rubber Dam must be used during root canal treatment
Irrigation technique:Passive by syringe and needle with gauge27
Control group:It's a group that is wash by sodium hypochlorite
Main outcome variables
type of irrigation
Inflammatory condition of dental pulp
Severe Periodontal Disease
Sensivity to Percussion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200517047478N1
Registration date:2020-08-20, 1399/05/30
Registration timing:registered_while_recruiting
Last update:2020-08-20, 1399/05/30
Update count:0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Sohrab Tour Savadkouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 5198
Email address
s_savadkouhi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of sodium Hypochlorite and Super oxidized water on Endodontic postoperative pain in human single canal tooth ( Clinical trial )
Public title
Effect of sodium Hypochlorite and Super oxidized water on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior single canal human teeth will chosen
The sample teeth should not have internal or external root resorption
Teeth which without calcification
Teeth which without caries in root
Root curvature of teeth Less than 15 degrees
All samples will have mature apex
All samples will have irreversible pulpaitis
The patient of choice should be without systemic disease.
The selected tooth has acute apical periodontitis.
The patient must be at least 18 years old and at most 65 years old
Exclusion criteria:
Teeth should not have restorations.
The patient should not have Severe periodontal disease.
Female patients should not be pregnant.
The patient should not be allergic to 2% lidocaine .
The patient should not use any drugs for at least 6 hours before treatment.
The target teeth should not have Sensitivity to Percussion
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization - Individual- Randomizitioan with closed envelop. each volunteer after meeting the inclusion criteria, randomly allocated by choosing the envelops containing special code which correlates to special irrigation solution in past.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know which solution to brush their teeth with. Clinical caregivers also do not know what detergent they are using
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad Tehran University of Medical Sciences
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.040
Health conditions studied
1
Description of health condition studied
Post Operative Pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Postopratrive pain in anterior teeth single canal
Timepoint
6h. 12h. 24h. 48h. 72h .7D
Method of measurement
Information form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teeth that are rinsed with superoxide water50%( khosro medisa teb)(KMT)
Category
Treatment - Devices
2
Description
Control group: Teeth that are rinsed with superoxide water 1%.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Islamic Azad University of Tehran
Full name of responsible person
Dr. Sohrab Tour Savadkouhi
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
S_savadkouhi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khosro medisa Teb
Full name of responsible person
Mrs .Khanban
Street address
Mollasadara
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8875 3442
Email
enquiry@kmtmed.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dental branch of Tehran Azad University of Medical Sciences
Proportion provided by this source
5
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Arash Azizi
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
S_savadkouhi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
90
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
Islamic Azad University
Full name of responsible person
Seyed Amirmasoud Mousavi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 6,Golestan 8Ave ,Ashrafi Esfahani Ave,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1471774691
Phone
+98 21 4406 6117
Email
masood975@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Sohrab tour Savadkouhi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_savadkouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedamirmasoudmousavi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ashrafi
City
Tehran
Province
Tehran
Postal code
1471774691
Phone
+98 21 4406 6117
Email
masood975@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some parts of data related to interventions are possible for sharing
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic or business
Under which criteria data/document could be used
Not possible
From where data/document is obtainable
Sohrab tour savadkouhi
Email: s_savadkouhi@yahoo.com
Mobile: 00989123803561
What processes are involved for a request to access data/document
Contacting with the correspondence and introducing himself
receiving the data within 1 month