Investigating the effect of dexamethasone as the final rinse inside the root canal compared to infiltration injection after the end of treatment in reducing pain after root canal treatment in patients with irreversible pulpitis.
Investigating the effect of dexamethasone as the final intra-canal rinse compared to infiltration injection after the end of treatment in reducing pain after root canal treatment in patients with irreversible pulpitis.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 96 patients.
Randomization was done using the free database "https://www.sealedenvelope.com/" with Seed=127686074750462.
Settings and conduct
1- Place of study: endodontics department, dental clinic, Bushehr University of Medical Sciences
2- Study population: 96 referring patients who need one-session root canal treatment in their molar teeth, 3- Blinding: blinding will be performed on both the patient and the evaluator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 years and older; diagnosis of symptomatic or asymptomatic irreversible pulpitis; absence of diabetes and cardiovascular diseases and allergic problems; willingness to cooperate; The possibility of one-session treatment; the possibility of achieving patency in all channels in radiography; the absence of periodontal problems. Exclusion criteria: the possibility of treatment complexity and prolonging the treatment time for more than 2 hours in radiography; history of gastric ulcer or gastrointestinal bleeding; history Hypersensitivity to NSAIDs or corticosteroids; risk of kidney damage.
Intervention groups
Intervention group 1: Dexamethasone infiltration near the tooth. Intervention group 2: Final rinsing of the canal with dexamethasone. Control group: no use of dexamethasone.
Main outcome variables
Average pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240109060657N1
Registration date:2024-02-12, 1402/11/23
Registration timing:prospective
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
mina seyed habashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 2206
Email address
msarlak269@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-14, 1402/11/25
Expected recruitment end date
2024-02-24, 1402/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of dexamethasone as the final rinse inside the root canal compared to infiltration injection after the end of treatment in reducing pain after root canal treatment in patients with irreversible pulpitis.
Public title
The effect of two methods of using dexamethasone in reducing pain after root canal treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients
Age over 18 years old
Vital pulp with a diagnosis of symptomatic or asymptomatic pulpitis
None of systemic diabetes and cardiovascular diseases and allergic problems
Willingness to cooperate
One-session root canal treatment
The possibility of achieving patency in all canals in preoperative radiography
Absence of periodontal problems
Exclusion criteria:
The complexity of the treatment and the possibility of prolonging the treatment time for more than 2 hours, which can be estimated from the patient's radiograph before starting the treatment.
History of gastric ulcer or gastrointestinal bleeding
History of allergy to NSAIDs or corticosteroids
Risk of renal failure or renal damage
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to three treatment groups A, B, C using the method of random blocks (Balance block randomization), the size of each block is 6 and the total number of blocks is 16 as described in the attached table. Randomization was done using the free database "https://www.sealedenvelope.com/" with Seed=127686074750462.
Therefore, in a randomized controlled clinical trial study, 32 patients in each group included local injection of dexamethasone (group A), final washing inside the canal with dexamethasone (group B) and no use of dexamethasone (group C) in reducing pain after molar root treatment. was included in the study in parallel.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the patients are unaware of the intervention group in which they are placed. Root canal treatment in patients is performed by the therapist (root canal treatment specialist) and the evaluation is done by the student who is unaware of the type of treatment intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Moallem blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2023-08-26, 1402/06/04
Ethics committee reference number
IR.BPUMS.REC.1402.117
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Average pain intensity
Timepoint
in the times before intervention, 3 hours after treatment, 6 hours, 12 hours, 24 hours after treatment
Method of measurement
NPRS ( Numeric Pain Rating Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: dexamethasone infiltration injection; After the end of the root treatment, a carpool (2 ml) of dexamethasone containing 8 mg of dexamethasone phosphate (as disodium salt) from Darou pakhsh company is infiltrated on the buccal side of the tooth.
Category
Treatment - Drugs
2
Description
Intervention group 2: final washing inside the canal with dexamethasone; After the preparation of the root canal and before filling the canal, the canal is washed with dexamethasone from Darou Pakhsh Company, and then the canal is dried and obturated.
Category
Treatment - Drugs
3
Description
Control group: not using dexamethasone; The patient does not receive any intervention with dexamethasone during root canal treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bushehr University of Medical Sciences
Full name of responsible person
مینا سید حبشی
Street address
Moallem Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
mina.s.habashi.64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Akram Farhadi
Street address
Moallem Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Email
ris@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
mina seyed habashi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moallem Blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
mina.s.habashi.64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mina Seyed Habashi
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moallem blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
mina.s.habashi.64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mina Seyed Habashi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moallem blvd
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
mina.s.habashi.64@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
Average amount of pain after treatment recorded by patients in all three groups and analysis of their results
When the data will become available and for how long
Beginning of the access period from 2024 to 2027
To whom data/document is available
The general public
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Mohammad Sarlak
Email: msarlak269@gmail.com
Phone: 09184900295
What processes are involved for a request to access data/document