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Trial registered on ANZCTR


Registration number
ACTRN12622000320752p
Ethics application status
Submitted, not yet approved
Date submitted
15/11/2021
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of combination of diclofenac sodium/acetaminophen versus combination of ibuprofen/acetaminophen in pulpal necrosis
Scientific title
Comparison of mean pain score using combination of diclofenac sodium/acetaminophen versus combination of ibuprofen/acetaminophen in symptomatic patients with pulpal necrosis
Secondary ID [1] 305770 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulpal necrosis 324291 0
Condition category
Condition code
Oral and Gastrointestinal 321782 321782 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
Root canal treatment of tooth is designed to eliminate bacteria from the infected root canal, prevent reinfection of the tooth and save the natural tooth. When one undergoes a root canal, the inflamed or infected pulp is removed and the inside of the tooth is carefully cleaned and disinfected, then filled and sealed. A root canal can take anywhere from 90 minutes to 3 hours. It can sometimes be done in one appointment but may require two. A root canal may be done by dentist or an endodontist. In our study Trainee endodontists have performed root canal treatment. The intervention drug(s) will be administered with respect to the surgical procedure, e.g. 1 hour post-procedure, etc. Under local anesthesia and rubber dam placement, access opening was started. Chemo-mechanical preparation of teeth was done in 1st visit and tooth was be temporized with cavit and patient was scheduled for next appointment. After 1 hour of procedure patient was advised to take medication for pain relief. Single dose of medicine after 1 hour of treatment that is Diclofenac sodium (50mg) and paracetamol(500mg) given to half of patients.







Intervention code [1] 322182 0
Treatment: Drugs
Comparator / control treatment

Drug 2- Ibuprofen/ Acetaminophen (400mg/500mg)
Duration- 1 tablet after 1 hour after procedure at the day of treatment only
Mode of administration- Oral route
Control group
Active

Outcomes
Primary outcome [1] 329566 0
Method of assessment is Mean pain score using a visual analogue scale VAS form given to patient to mark the score of pain after 6 hour of treatment and bring the form on next appointment.
Timepoint [1] 329566 0
6 hours after the first visit of treatment procedure
Secondary outcome [1] 403009 0
None
Timepoint [1] 403009 0
None

Eligibility
Key inclusion criteria
Teeth with pulpal necrosis having moderate to severe pain at the time of treatment ranging from 5-10 on visual analogue scale VAS (0-10)
Teeth negative to Cold test and Electric pulp tester
Periapical radiograph with minimum 2×2mm radiolucency at the apex
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with history of Gastrointestinal disorder (GIT) disorders, respiratory disorder, decreased hepatic function, hemorrhagic disorder, poorly controlled Diabetes Mellitus, allergic to ibuprofen, diclofenac sodium or acetaminophen, pregnant women and nursing mother.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The collected data will be analyzed by Statistical package for Social Sciences (SPSS version 22.0).
Descriptive statistics will be used to calculate qualitative and quantitative variables. Qualitative variables like gender will be measured as frequency and %.
Quantitative variable like (age and mean pain score) will be measured as mean and standard deviation.
Independent sample T-test will use to compare mean pain score between two groups. P-Value = 0.05 will be considered significant.
Effect modifiers like age, gender will be controlled by stratification.
Post stratification independent sample T-test will be applied.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
30/08/2022
Actual
Date of last data collection
Anticipated
30/08/2022
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment outside Australia
Country [1] 24324 0
Pakistan
State/province [1] 24324 0
Islamabad

Funding & Sponsors
Funding source category [1] 310128 0
Self funded/Unfunded
Name [1] 310128 0
Rabia Qamar
Country [1] 310128 0
Pakistan
Primary sponsor type
Individual
Name
Quratulain Khan
Address
Assistant Professor
Shifa College of Dentistry, Shifa Tameer e Millat University
Dhoke Kala Khan, Expressway Islamabad, 44000
Pakistan
Country
Pakistan
Secondary sponsor category [1] 311199 0
None
Name [1] 311199 0
none
Address [1] 311199 0
none
Country [1] 311199 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309816 0
Rawal Institute of Health Sciences
Ethics committee address [1] 309816 0
Rawal Institute of Health Sciences/ Rawal Dental Hospital Park Road Islamabad Pakistan 44000
Ethics committee country [1] 309816 0
Pakistan
Date submitted for ethics approval [1] 309816 0
01/01/2022
Approval date [1] 309816 0
Ethics approval number [1] 309816 0

Summary
Brief summary
To compare mean pain score using combination of diclofenac sodium/paracetamol versus combination of ibuprofen/paracetamol after instrumentation of root canals in symptomatic patients with pulpal necrosis.
It is hypothesized that single oral dose of diclofenac sodium and paracetamol combination offer better pain control than ibuprofen and paracetamol combination following root canal preparation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115486 0
A/Prof Quratulain Khan
Address 115486 0
Assistant Professor Operative Dentistry & Endodontics
Shifa College of Dentistry, Shifa Tameer e Millat University
Dhoke Kala Khan, Expressway, Islamabad
44000
Pakistan
Country 115486 0
Pakistan
Phone 115486 0
+923315035247
Fax 115486 0
Email 115486 0
[email protected]
Contact person for public queries
Name 115487 0
Quratulain Khan
Address 115487 0
Assistant Professor Operative Dentistry & Endodontics
Shifa College of Dentistry, Shifa Tameer e Millat University
Dhoke Kala Khan, Expressway, Islamabad
44000
Pakistan
Country 115487 0
Pakistan
Phone 115487 0
+923315035247
Fax 115487 0
Email 115487 0
[email protected]
Contact person for scientific queries
Name 115488 0
Quratulain Khan
Address 115488 0
Assistant Professor Operative Dentistry & Endodontics
Shifa College of Dentistry, Shifa Tameer e Millat University
Dhoke Kala Khan, Expressway, Islamabad
44000
Pakistan
Country 115488 0
Pakistan
Phone 115488 0
+923315035247
Fax 115488 0
Email 115488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
for patient confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



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.