the effect of smear layer removal on postoperative pain in necrotic teeth with chronic apical periodontitis
Design
Using the Rand option of Excel software, the samples will be divided into 4 blocks by Complete Block Randomization method. The type of intervention is in numbered sealed envelopes and will be provided to the researcher.The researcher will open the envelope immediately before starting work and will be informed about the type of specialized intervention. The study is single blinded.
Settings and conduct
this intervention is performed by 9th semester students of Tehran Azad Dental School
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 to 60 years, good health (ASA I - ASA II) will be determined through medical history.
Tooth inclusion criteria: maxilla and mandible single canal teeth no response to vital tests, no sensitivity to percussion, no history of pervious endodontic treatment that have chronic apical periodontitis with periapical index between 3 to 5.
Exclusion criteria: People outside the age group of 18 to 60 years, pregnant, with systemic disease, history of allergy or toxic reaction to anesthesia and usage of analgesic drug within 6 hours before endodontic treatment will be excluded from the study.
Tooth exclusion criteria: Multichannel teeth, teeth with a lesion size greater than 8 mm and the presence of Severe Periodontal Disease will be excluded
Intervention groups
Intervention group: In this group of 36 people after preparation by Step Back method and rinsing with 1%sodium hypochlorite, in order to remove smear layer, 5mL of 17% EDTA will be used for 1 minute and then 2mL of 5.25% sodium hypochlorite for 30 seconds.
Control group:in this group of 36 people smear layer won't be removed and 2mL of normal saline will be used for final rinsing
Main outcome variables
Postoperative pain in case and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200517047478N2
Registration date:2021-06-02, 1400/03/12
Registration timing:registered_while_recruiting
Last update:2021-06-02, 1400/03/12
Update count:0
Registration date
2021-06-02, 1400/03/12
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
2021-05-31, 1400/03/10
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of smear layer removal on postoperative pain in necrotic teeth with chronic apical periodontitis
Public title
effect of smear layer removal on postoperative pain in necrotic teeth with chronic apical periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with ASA1- ASA2
necrotic single canal teeth in maxilla and mandible are chosen
teeth should not have sensitivity to percussion
teeth should have chronic apical periodontitis with periapical index 3 to 5
patients must be between 18 and 60 years old
teeth should not have internal or external root resorption
root curvature should be less than 30 degrees
Exclusion criteria:
patients who are less than 18 years old or more than 60 yeas old
pregnant women
patients with systemic diseases
patients with history of allergic reaction to local anesthesia
The patient should not use any drugs for at least 6 hours before treatment.
multi canal teeth
teeth with more than 8mm lesion size
teeth with severe periodontal disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand option of Excel software, the samples will be divided into 4 blocks by complete block randomization method. This process is performed by a person who is not present in the clinical work and follow-up of patients (statistics and methodology consultant) and the type of intervention will be provided to the researcher in envelopes in numbered packages and the researcher will open the lock immediately The type of specialized intervention will be informed.
Blinding (investigator's opinion)
Single blinded
Blinding description
patients do not know which intervention is being performed on them
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
2021-05-22, 1400/03/01
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.018
Health conditions studied
1
Description of health condition studied
postoperative pain
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Postoperative pain in single canal teeth
Timepoint
6h. 12h. 24h. 48h. 72h .7D
Method of measurement
information form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of 36 people after preparation by Step Back method and rinsing with 1%sodium hypochlorite, in order to remove smear layer, 5mL of 17% EDTA will be used for 1 minute and then 2mL of 5.25% sodium hypochlorite for 30 seconds
Category
Treatment - Other
2
Description
Control group: in this group of 36 people smear layer won't be removed and 2mL of normal saline will be used for final rinsing.
Category
Treatment - Other
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
Islamic Azad University
Full name of responsible person
Dr.Arash Azizi
Street address
tehran
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
100
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
Azin Pourmohammad
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
pasdaran
City
tehran
Province
Tehran
Postal code
1956819111
Phone
+98 21 2256 4571
Email
azinpd1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sohrab Tour Savadkouhi
Position
Assistant 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
Azin Pourmohammad
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
tehran
City
tehran
Province
Tehran
Postal code
1956819111
Phone
+98 21 2256 4571
Email
Azinpd1@gmail.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
6 months after publication
To whom data/document is available
people who work at university
Under which criteria data/document could be used
not possible
From where data/document is obtainable
Sohrab tour savadkouhi Email: s_savadkouhi@yahoo.com
What processes are involved for a request to access data/document
Contacting with the correspondence and introducing himself receiving the data within 1 month