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Trial registered on ANZCTR


Registration number
ACTRN12622000633785
Ethics application status
Approved
Date submitted
31/03/2022
Date registered
28/04/2022
Date last updated
18/09/2023
Date data sharing statement initially provided
28/04/2022
Date results provided
3/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
To check the efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis after premedication with ketorolac and diclofenac potassium
Scientific title
Effect of prophylactically administered ketorolac and diclofenac potassium on the efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis.
Secondary ID [1] 306797 0
Nil
Universal Trial Number (UTN)
U1111-1276-5027
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Irreversible Pulpitis 325865 0
Condition category
Condition code
Oral and Gastrointestinal 323176 323176 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of premedication with single dose of tablet Ketorolac (10mg) given orally, 1 hour prior to initiation of root canal treatment, on the efficacy of Inferior alveolar nerve block (IANB) in patients presenting with symptomatic irreversible pulpitis.
The drug will be given to the patient to be taken by oral route under supervision of principal investigator and mouth check will be done to check adherence to the intervention. 1 hour after premedication with the drug, nerve block will be administered by the principal investigator and patient will be asked about feeling of lip numbness to confirm the onset of anesthesia, 15 mins after administration of nerve block. The drug used for IANB will be 1.8 mL of 2% lidocaine containing 1: 200 000 epinephrine (Septodont). The effect of nerve block will be cross checked with cold test using Ethyl chloride spray. If cold test shows negative response then root canal procedure will be initiated after rubber dam isolation. The approximate duration of root canal procedure will be 45 minutes.
Intervention code [1] 323257 0
Treatment: Drugs
Comparator / control treatment
The effect of premedication with single dose of tablet Diclofenac Potassium (50mg) given orally, 1 hour prior to initiation of root canal treatment, on the efficacy of Inferior alveolar nerve block (IANB) in patients presenting with symptomatic irreversible pulpitis.
The drug will be given to the patient to be taken by oral route under supervision of principal investigator and mouth check will be done to check adherence to the intervention. 1 hour after premedication with the drug, nerve block will be administered by the principal investigator and patient will be asked about feeling of lip numbness to confirm the onset of anesthesia, 15 mins after administration of nerve block. The drug used for IANB will be 1.8 mL of 2% lidocaine containing 1: 200 000 epinephrine (Septodont). The effect of nerve block will be cross checked with cold test using Ethyl chloride spray. If cold test shows negative response then root canal procedure will be initiated after rubber dam isolation. The approximate duration of root canal procedure will be 45 minutes. The effect of both drugs will be compared with each other.
Control group
Active

Outcomes
Primary outcome [1] 330932 0
Pain assessed through Visual Analogue Scale during access cavity preparation and root canal instrumentation
Timepoint [1] 330932 0
Pain score will be recorded on Visual Analogue Scale once during access cavity preparation and once during root canal instrumentation when initial file of size 10-K is used for scouting of canals. The time duration between both time points will be approximately 5 minutes.
Secondary outcome [1] 408234 0
Nil
Timepoint [1] 408234 0
Nil

Eligibility
Key inclusion criteria
Healthy adult patients
Age 18 - 60 years
First and second mandibular molars with history of Symptomatic Irreversible Pulpitis
Moderate or severe pain score on Visual Analogue Scale
No premedication with any drug 12 hours prior to treatment
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any known allergy to NSAID medication or lignocaine
Pregnant females
Lactating females
Those who will not be able to give informed consent
Patients with active peptic ulcers
Teeth declared necrotic upon investigation with cold test using ethyl chloride
Patients only experiencing mild pain (0-3) on Visual Analogue Scale

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment with sealed opaque containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization with coin flipping
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is calculated with WHO calculator, using test for two independent proportions, with anticipated population proportion of Ketorolac group as 0.76 and Diclofenac potassium as 0.54, keeping the power of test 80% and significance level 5%, according to a study by Saha et al . Total sample size will be 130.

Data will be recorded and analyzed on SPSS (Version 23). . Mean and standard deviation will be calculated for quantitative variables like age, Pre and Post VAS pain score. Frequency and percentages will be calculated for qualitative variables like age groups, gender and efficacy of anesthesia. Both drug groups (Ketorolac and Diclofenac potassium) will be cross-tabulated with efficacy of anesthesia of IANB and Chi-square test will be applied. Effect modifiers like age groups and gender will be considered by stratification. Post stratification Chi-square test will also be applied. P value of 0.05 or less will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2022
Actual
2/05/2022
Date of last participant enrolment
Anticipated
2/08/2022
Actual
14/12/2022
Date of last data collection
Anticipated
2/08/2022
Actual
14/12/2022
Sample size
Target
130
Accrual to date
Final
130
Recruitment outside Australia
Country [1] 24700 0
Pakistan
State/province [1] 24700 0
Rawalpindi, Punjab

Funding & Sponsors
Funding source category [1] 311135 0
Self funded/Unfunded
Name [1] 311135 0
Dr. Sara Bano
Country [1] 311135 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Sara Bano
Address
Shifa College of Dentistry, Chaudhry Ghulam Abbas Road, 996 Service Rd West, Dhoke Kala Khan, Post code 44000, Rawalpindi, Punjab, Pakistan
Country
Pakistan
Secondary sponsor category [1] 312478 0
None
Name [1] 312478 0
n/a
Address [1] 312478 0
n/a
Country [1] 312478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310661 0
Ethical review committee of Armed Forces Institute of Dentistry, CMH Road, Lalkurti, Rawalpindi
Ethics committee address [1] 310661 0
Ethics committee country [1] 310661 0
Pakistan
Date submitted for ethics approval [1] 310661 0
17/01/2022
Approval date [1] 310661 0
10/02/2022
Ethics approval number [1] 310661 0
90/Trg – ABP1K2,

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118434 0
Dr Sara Bano
Address 118434 0
Shifa College of Dentistry, Chaudhry Ghulam Abbas Road, 996 Service Rd West, Dhoke Kala Khan, Post code 44000, Rawalpindi, Punjab, Pakistan
Country 118434 0
Pakistan
Phone 118434 0
+923325106651
Fax 118434 0
Email 118434 0
sarabano67@gmail.com
Contact person for public queries
Name 118435 0
Sara Bano
Address 118435 0
Shifa College of Dentistry, Chaudhry Ghulam Abbas Road, 996 Service Rd West, Dhoke Kala Khan, Post code 44000, Rawalpindi, Punjab, Pakistan
Country 118435 0
Pakistan
Phone 118435 0
+923325106651
Fax 118435 0
Email 118435 0
sarabano67@gmail.com
Contact person for scientific queries
Name 118436 0
Sara Bano
Address 118436 0
Shifa College of Dentistry, Chaudhry Ghulam Abbas Road, 996 Service Rd West, Dhoke Kala Khan, Post code 44000, Rawalpindi, Punjab, Pakistan
Country 118436 0
Pakistan
Phone 118436 0
+923325106651
Fax 118436 0
Email 118436 0
sarabano67@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data record of individual patients including, name, age, gender, type of drug intervention used, tooth number in FDI system, pre-injection VAS and post injection VAS score
When will data be available (start and end dates)?
After completion of data collection i.e, 2nd August, 2022
It will remain available for 5 years after publication
Available to whom?
To everyone who wishes to access
Available for what types of analyses?
Available for proposed study, systematic reviews and meta analysis
How or where can data be obtained?
Data will be accessible through Mendeley Data

Link for data: https://data.mendeley.com/datasets/gkr53hmkmk/draft?a=9adc7a9b-0696-4f39-9fd6-66feb5057b52

Contact information of Principal Investigator:
Dr. Sara Bano
sarabano67@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15640Ethical approval    383844-(Uploaded-31-03-2022-21-26-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.