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Evaluation of the effect of lidocaine 2%-dexamethasone composition and compare it with lidocaine 2% injection on postoperative endodontic pain

Protocol summary

Study aim
Determining and comparing the effect of injection of 2% lidocaine, dexamethasone and 2% lidocaine on pain after root canal treatment.
Design
Randomized and double-blind clinical trial with parallel randomized groups, for 108 patients. Randomization using RA software.
Settings and conduct
The study will be done in the endodontist's ffice in Shahrekord. Before starting the treatment, a syringe containing 0.4 mg of dexamethasone and 1.8 mg of 2% lidocaine(100,000 epinephrine)or a syringe containing 1 ml of normal saline (placebo) and 1.8 mg with 2% lidocaine is prepared and injected. How to evaluate and record the incidence and severity of pain, immediately after treatment and at 6, 12, 24, 48 hours after treatment will be through patient registration in the VAS questionnaire
Participants/Inclusion and exclusion criteria
People with ASA I and ASA II, teeth with no history of pulp therapy, pulp condition as irreversible pulpitis to necrosis, periapical condition as acute or chronic periodontitis, no use of painkillers and anti-inflammatory drugs in the last 12 hours, absence of abscess acute or chronic periapical and acute periodontal abscess, no need to take preventive antibiotics, no pregnancy, no mental disability, literate, no systemic disease prohibiting root canal treatment, no infectious disease or sensitivity To dexamethasone, lack of opening of the apex of the tooth The non-entry conditions are the opposite of the entry conditions.
Intervention groups
1. 4 mg dexamethasone + 1.8 mg lidocaine 2. 1 ml normal saline + 1.8 mg lidocaine
Main outcome variables
Management and prevention of pain after root canal treatment,Determining and comparing the effect of injection of 2% lidocaine, dexamethasone and 2% lidocaine on pain after root canal treatment in the upper and lower jaws, according to the condition of the dental pulp, age, gender, type of tooth and systemic condition of the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240729062577N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: registered_while_recruiting

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Zahra Rajaei khouzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3363 1858
Email address
st-rajaee@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lidocaine 2%-dexamethasone composition and compare it with lidocaine 2% injection on postoperative endodontic pain
Public title
evaluation of dexamethasone injection on pain after root canal treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people with ASA I and ASA II The tooth has no history of pulp therapy The state of the pulp is irreversible pulpitis to necrosis Periapical condition of the tooth as acute or chronic periodontitis Not taking painkillers and anti-inflammatory drugs in the last 12 hours Absence of acute or chronic periapical abscess and acute periodontal abscess No need to take prophylactic antibiotics Absence of pregnancy Absence of mental disability Literate to read and write Absence of systemic disease prohibiting root canal treatment Absence of infectious disease or sensitivity to dexamethasone Absence of tooth apex opening
Exclusion criteria:
People with ASA III and ASA IV A tooth that requires multiple treatment sessions Age more than 60 and less than 12 years
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to two groups using the permutation block method. For this purpose, 18 blocks with a volume of 6 will be prepared by RA software and provided to a person who is not aware of the content of the interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants will be assigned to two groups using permutation blocks. For this purpose, 18 blocks with a volume of 6 will be prepared by the RA software and will be provided to a person who is not aware of the content of the interventions. One group will receive the combination of lidocaine and dexamethasone and one group will receive the combination of normal saline and lidocaine, but the clinical caregiver and the data analyst will not know about the injection combination, and only the researcher who is responsible for preparing the anesthetic combination and filling the patient's file will know.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Medicine - Shahrekord University of Medical Sciences (Research Ethics Committee)
Street address
Kashani Blvd., University Headquarters
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2024-07-03, 1403/04/13
Ethics committee reference number
IR.SKUMS.MED.REC.1403.048

Health conditions studied

1

Description of health condition studied
Pain after root canal treatment in periapical tissues
ICD-10 code
K04
ICD-10 code description
Diseases of pulp and periapical tissues

Primary outcomes

1

Description
Pain level after root canal treatment
Timepoint
immediately and 6, 12, 24 and 48 hours after the root treatment
Method of measurement
Using the Visual Analogue Scale pain questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A syringe containing 4 mg of dexamethasone (equivalent to 1 ml) and 1.8 mg of 2% lidocaine containing 100,000 epinephrine is used for anesthesia
Category
Treatment - Drugs

2

Description
Control group: They receive a syringe containing 1 ml of normal saline (placebo) and 1.8 mg and 2% lidocaine containing epinephrine 100,000 for sedation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ameneh Shareghi office with a specialized doctorate in endodontics
Full name of responsible person
Ameneh Shareghi
Street address
The office of Dr. Ameneh Shareghi, a specialist in root canal therapy, 1st floor,Ordibehesht building, 48th alley, Molavi street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816786463
Phone
+98 38 3222 1585
Email
st-rajaee@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Omrani
Street address
University headquarters, Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Rajaei khouzani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7, Alley 35, South Shariati Street, Shohada Square
City
Khomeini shahr
Province
Isfehan
Postal code
8414937171
Phone
+98 31 3363 1858
Fax
Email
st-rajaee@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Rajaei khouzani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7, Alley 35, South Shariati Street, Shohada Square
City
Khomeini shahr
Province
Isfehan
Postal code
8414937171
Phone
+98 31 3363 1858
Fax
Email
st-rajaee@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Rajaei khouzani
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 7, Alley 35, South Shariati Street, Shohada Square
City
Khomeini shahr
Province
Isfehan
Postal code
8414937171
Phone
+98 31 3363 1858
Fax
Email
st-rajaee@skums.ac.ir

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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