Effect of Premedication with Ibuprofen and Dexamethasone on Success Rate of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis: A Randomized Clinical Trial
The aim of this study is to compare the effectiveness of Ibuprofen and Dexamethasone in reduction of frequency of pain after giving inferior alveolar nerve block to teeth with irreversible pulpitis.
Design
Randomized Controlled Trial
Settings and conduct
The study conducted at the Operative Dentistry department of Watim Dental College and Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with pain VAS≥6 in mandibular molar having irreversible pulpitis
2. Patients who are not taking any antibiotics, anti-inflammatory or analgesics for at least one-week prior treatment
3. Patients between the ages 18-60 years
4. Both males and females
Exclusion criteria:
1. Patients with any known allergies
2. Patients with a history of active peptic ulcer
3. Patients with osteoporosis
4. Pregnant or breast-feeding females
5. Patients with immunosuppression
Intervention groups
The patients were divided into two groups according to the selection used for medication: Group A received Ibuprofen 400 mg or Group B received Dexamethasone 0.5mg, with 30 patients in each group.
Main outcome variables
The patient was asked to rate their pain according to the Heft Parker visual analogue scale. The degree to which the drug was successful in minimizing pain (VAS≤54) within four hours of treatment was deemed effective.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240830062905N1
Registration date:2024-09-23, 1403/07/02
Registration timing:retrospective
Last update:2024-09-23, 1403/07/02
Update count:0
Registration date
2024-09-23, 1403/07/02
Registrant information
Name
Hafsa Khalil
Name of organization / entity
Smart Consultancy for clinical research
Country
Pakistan
Phone
+92 334 1101305
Email address
sadafamjad@watim.com.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-01, 1402/03/11
Expected recruitment end date
2023-10-30, 1402/08/08
Actual recruitment start date
2023-06-15, 1402/03/25
Actual recruitment end date
2023-12-01, 1402/09/10
Trial completion date
2024-01-17, 1402/10/27
Scientific title
Effect of Premedication with Ibuprofen and Dexamethasone on Success Rate of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis: A Randomized Clinical Trial
Public title
Effect of Premedication with Ibuprofen and Dexamethasone on Success Rate of Inferior Alveolar Nerve Block for Teeth with Irreversible Pulpitis: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with pain (VAS≥114) in mandibular molar having irreversible pulpitis confirmed by cold test using ethyl chloride,
patients who were not taking any antibiotics, anti-inflammatory or analgesics for at least one-week prior to treatment.
Both males and females were included
age 18-60 years.
Exclusion criteria:
1. Patients with any known allergies
Patients with a history of active peptic ulcer
Patients with osteoporosis
Pregnant or breast-feeding females
Patients with immunosuppression
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients requiring treatment for irreversible pulpitis were randomly assigned into two groups : Ibuprofen 400 mg or Dexamethasone 0.5mg (30 patients in each group). Patients were allocated to the medication group randomly using computer generated random number table. Aside from the case selection, all the clinical procedures were executed by a single endodontist (who was not part of the study process) and had no involvement with the study outcome.
Blinding (investigator's opinion)
Double blinded
Blinding description
To ensure blinding, neither the patient nor the operator had knowledge about the medication used as all medications were removed from their original containers and placed in new ones. In addition, allocation sequence was concealed from researchers who were part of the study to reduce bias. The patients were divided into two groups according to the selection used for medication: Group A (Ibuprofen 400 mg) or Group B (Dexamethasone 0.5mg), with 30 patients in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Watim medical and dental college
Street address
Watim medical and dental college, main G.T road, Near T-chowk, Rawat Pakistan
City
Rawalpindi
Postal code
46000
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
WM&DCR/R&D (ERB)/2023/35
Health conditions studied
1
Description of health condition studied
Patients with irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain reduction
Timepoint
before and after 4 hours after the treatment
Method of measurement
Analogue Pain scale (VAS≤3) with scoring 1-10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group-1: Dexamethasone with single dose of 0.5mg was given orally one hour prior to Inferior alveolar nerve block injections (IANB)
Category
Treatment - Drugs
2
Description
Intervention group-2: Ibuprofen with single dose of 400 mg was given orally one hour prior to Inferior alveolar nerve block injections (IANB)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Watim Medical and Dental College, Rawalpindi
Full name of responsible person
Sadaf Amjad
Street address
H no. 520, St#17, Sector-III, Airport housing society, Rawalpindi Pakistan
City
Rawalpindi
Postal code
46000
Phone
+92 334 1101305
Email
hafsakhalil100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Watim Medical and Dental College
Full name of responsible person
Sadaf Amjad
Street address
Watim Medical and Dental College, main G.T road, Rawat
City
Rawalpindi
Postal code
46000
Phone
+92 300 5126514
Email
sadafamjad986@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Watim Medical and Dental College
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Watim Medical and Dental College, Rawalpindi
Full name of responsible person
Sadaf Amjad
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
11b, street 28, block F, naval anchorage, Islamabad
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 300 5126514
Email
sadafamjad986@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Watim Medical and Dental College, Rawalpindi
Full name of responsible person
Sadaf Amjad
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
11b, street 28, block F, naval anchorage, Islamabad
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 300 5126514
Email
sadafamjad986@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Watim Medical and Dental College, Rawalpindi
Full name of responsible person
Sadaf Amjad
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
11b, street 28, block F, naval anchorage, Islamabad
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 300 5126514
Email
sadafamjad986@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