Comparison of Premedication Using Ibuprofen and Meloxicam on the success rate of Inferior Alveolar Nerve Block in mandibular first molars with symptomatic Irreversible Pulpitis
Comparison of Premedication Using Ibuprofen and Meloxicam on success rate of Inferior Alveolar Nerve Block in mandibular first molars with symptomatic Irreversible Pulpitis
Design
A clinical trial with parallel intervention groups, double-blind, randomized, on 165 patients. The sampling method is random. Randomization using a table of random numbers is the Random Allocation Software.
Settings and conduct
Random sampling will be done among the patients referred to the endodontics department of Tabriz Faculty of Dentistry who are eligible for the study. Patients are randomly assigned to one of the groups. One hour before the start of the treatment, Ibuprofen 800 mg capsule will be used in group A, Meloxicam 15 mg capsule in group B, and placebo capsule (lactose powder) in group C. Before starting the treatment, their pain level is recorded. Then, all patients are under the same anesthesia. The success or failure of lip anesthesia is recorded. During the treatment, the amount of pain is determined. The patient is aware of the existence of several types of treatment, but he does not know which group he is in, and the researcher is not aware of the type of medicine.
Participants/Inclusion and exclusion criteria
Including: First molar teeth of the lower jaw with the diagnosis of symptomatic irreversible pulp inflammation, willingness to participate in the study
Excluding: Signs of radiolucency around the apex of the roots, use of painkillers within 12 hours before treatment, having a full crown or partial necrosis in the studied tooth, teeth with previous root treatment, advanced periodontal disease
Intervention groups
Intervention 1: Use Ibuprofen 800 mg capsule one hour before the treatment
Intervention 2: Use Meloxicam 15 mg capsule one hour before treatment
Placebo: Use a lactose powder capsule one hour before treatment
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220909055923N1
Registration date:2022-09-10, 1401/06/19
Registration timing:registered_while_recruiting
Last update:2022-09-10, 1401/06/19
Update count:0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Behzad Sheikhfaal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 533 5279
Email address
b.sh11399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-10, 1401/06/19
Expected recruitment end date
2022-10-10, 1401/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Premedication Using Ibuprofen and Meloxicam on the success rate of Inferior Alveolar Nerve Block in mandibular first molars with symptomatic Irreversible Pulpitis
Public title
The effect of Ibuprofen and Meloxicam on dental anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy
A history of spontaneous, or severe pain during cold testing
Age 20-40 years
Exclusion criteria:
Suffering from systemic diseases
Allergy to one of the following: Lidocaine, Epinephrine, NSAIDs, Dexamethasone, Caffeine
Suffering from asthma, coagulation disorder, nervous and mental disorder, diseases of immune system defects
Pregnancy and breastfeeding for women
Allergy to the anesthetic
Having a heart pace-maker
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be done among the patients referred to the endodontics department of Tabriz Faculty of Dentistry who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with code A (Ibuprofen), B (Meloxicam), and code C (placebo/powdered lactose) and placed inside sealed envelopes. Then the envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. None of the patients will be informed about the treatment of another patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, and the patients do not know about the type of group they will be included in. A researcher will not know about the type of medicine. Patients are aware of the existence of several types of treatment, but they do not know which group they belong to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.495
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
The amount of pain
Timepoint
Before and during root canal treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ibuprofen capsule 800 mg (Reha Pharmaceuticals) will be used one hour before root canal treatment. Before starting the treatment, their pain level is recorded. One hour after the oral administration of the capsule, all patients are under lidocaine and epinephrine anesthesia. 15 minutes later, the success or failure of lip anesthesia is recorded. During the treatment, the amount of pain is determined in groups.
Category
Treatment - Drugs
2
Description
Intervention group 2: Meloxicam 15 mg capsules (Iran Daru Pharmaceuticals) will be used one hour before the root canal treatment. Before starting the treatment, their pain level is recorded. One hour after the oral administration of the capsule, all patients are under lidocaine and epinephrine anesthesia. 15 minutes later, the success or failure of lip anesthesia is recorded. During the treatment, the amount of pain is determined in groups.
Category
Treatment - Drugs
3
Description
Placebo group: A lactose powder capsule (prepared by the pharmacist) will be used one hour before root canal treatment. Before starting the treatment, their pain level is recorded. One hour after the oral administration of the capsule, all patients are under lidocaine and epinephrine anesthesia. 15 minutes later, the success or failure of lip anesthesia is recorded. During the treatment, the amount of pain is determined in groups.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz
Full name of responsible person
Mohammad Forough Reyhani
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
moh_reyhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mozhgan Kachuei
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
moh_reyhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Forough Reyhani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
moh_reyhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Forough Reyhani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
moh_reyhani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Forough Reyhani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 44 3344 4598
Email
moh_reyhani@yahoo.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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