Protocol summary

Study aim
The effect of endoactivator on pain after treatment of necrotic teeth with chronic apical periodontitis
Design
The clinical trial is parallel, single-blind, with a placebo, randomized, on 44 patients. Randomization will be done using a table of random numbers, and allocation concealment with the sealed envelope method.
Settings and conduct
This is a clinical trial study on 44 patients with necrotic teeth with chronic apical periodontitis score 2 or 3, which is diagnosed by radiography and negative cold test, single root and single canal, who refer to Azad Faculty of Dentistry in Tehran for routine endodontic treatment. will be done Washing is done in both groups using 40 ml of 5.0% NaOCl. Standard washing is done using a 5 cc 30 gauge syringe and a side hole made of stainless steel. For the induction group, the tip of the device continuously injects 5.0% NaOCl into the channel entrance for one minute. To check the pain after the treatment, we ask the patients to evaluate the intensity of the pain after the operation on the VAS scale at 8, 24, 48, and 72 hours after the visit.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 and 65 years, a necrotic tooth with chronic apical periodontitis score 2 or 3. Exclusion criteria: pregnant or lactating patients, patients who are allergic to non-steroidal anti-inflammatory drugs.
Intervention groups
For the control group, standard washing is done using a 5 cc 30 gauge syringe and a side hole made of stainless steel. For the induction group, the tip of the device continuously injects 0.5% NaOCl into the canal entrance for one minute.
Main outcome variables
Occurrence of Postoperative Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230707058704N1
Registration date: 2023-07-25, 1402/05/03
Registration timing: prospective

Last update: 2023-07-25, 1402/05/03
Update count: 0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Matine Mahmudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 8929
Email address
mahmudimatin1377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Endoactivator on Postoperative Pain in necrotic teeth with Apical Periodontities, a Clinical Trial Study
Public title
The Effect of Endoactivator on Postoperative Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A tooth with a mature apex and no root decay Teeth without cracks and fractures Teeth without internal or external analysis Calcification and previous root treatment
Exclusion criteria:
Pregnant or lactating patients Patients who use painkillers or any anti-inflammatory drugs Patients who are allergic to non-steroidal anti-inflammatory drugs The tooth cannot be isolated
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the simple randomization method of the random number table type. Since the total number of study subjects is 44 people and a two-digit number, we give each person a two-digit code. Then, to select sample people from the table, by closing the eyes and putting the tip of the pen on the table, starting from a point of the table in the direction of the row or column, and taking into account that the code of each person is two digits, we start choosing two-digit numbers. The selected number is actually the code of an individual from the community that is selected as a sample. This continues until the number of people in the inducer group sample (22 people) can be chosen smaller than 44..In order to conceal, we use concealment allocation, which is the method used to perform a random sequence on the study participants, in such a way that the assigned group is not known before the allocation of the individual. Using opaque envelopes sealed with a random sequence (envelopes opaque, sealed, numbered sequentially), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order They are placed.In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining the consent form and general introduction of the study groups to the participants, the information that can cause the test result to deviate remains hidden from the participant's view, but the person responsible for conducting the test is aware of them and the study is conducted in a single blind manner.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No.166, 7th bustan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666613966
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.028

Health conditions studied

1

Description of health condition studied
necrotic teeth with apical periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis

Primary outcomes

1

Description
Pain score after root canal treatment in Visual Analogue Scale
Timepoint
Measurement of pain intensity 12 hours before treatment and 8, 24, 48 and 72 hours after root canal treatment.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: washing the canal with an induction activator, so that the tip of the device continuously injects 0.5% sodium hypochlorite into the entrance of the canal for one minute, and each washing cycle includes placing the tip during operation for 6 seconds and then placing it in It is two millimeters shorter than the working length for another 6 seconds and repeat this again for 30 seconds.
Category
Treatment - Devices

2

Description
Control group: standard washing is done using a 5cc 30 gauge syringe with a side hole made of stainless steel, the needle goes to 3 mm working length and washing is done with 0.5% sodium hypochlorite and 17% EDTA for one minute.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry-Islamic Azad University of Medical Sciences, Tehran
Full name of responsible person
Matine Mahmudi
Street address
No. 9, Pasdaran St., Neyestan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_savadkoohi@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sohrab Tor Sawad Kohi
Street address
No. 9, Pasdaran St., Neyestan 9th
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_savadkoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This study is carried out independently by the student, and Tehran Azad Dental School provides the necessary background for conducting the study and field facilities and is a financial supporter.
Proportion provided by this source
100
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Matine Mahmudi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.166, 7th Bustan St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
166661396
Phone
+98 21 2258 8929
Fax
Email
mahmudimatin1377@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Matine Mahmudi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.166, 7th Bustan St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
166661396
Phone
+98 21 2258 8929
Fax
Email
mahmudimatin1377@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Matine Mahmudi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.166, 7th Bustan St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
166661396
Phone
+98 21 2258 8929
Fax
Email
mahmudimatin1377@gmail.com

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
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