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Comparison of combination of diclofenac sodium/acetaminophen versus combination of ibuprofen/acetaminophen in pulpal necrosis

Comparison of mean pain score using combination of diclofenac sodium/acetaminophen versus combination of ibuprofen/acetaminophen in symptomatic patients with pulpal necrosis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000320752
Enrollment
330
Registered
2022-02-21
Start date
2022-03-01
Completion date
2022-08-30
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Quratulain Khan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026