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Pain, PostoperativePhase 4NCT04947566

Comparison of Efficacy of Naproxen Versus Ibuprofen

A Phase 4 study testing Comparison of Efficacy of Naproxen versus Ibuprofen in people with Pain, Postoperative, run by Fatima Memorial Hospital at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparison between Naproxen and Ibuprofen in management of post operative endodontic pain was done.Total 116 patients were selected and divided in to two groups.One group was given Naproxen and other was given Ibuprofen. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative
What is being tested?
Comparison of Efficacy of Naproxen versus Ibuprofen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
2 sitesPakistan
Study dates
2 Sep 2019to 25 Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Age range 20-40 years
  • Gender- either
  • Teeth with acute Irreversible pulpitis assessed by Electric pulp tester lasting more than 30 seconds
  • One tooth per arch with no opposing tooth involved

Who cannot join

  • Patients who reported to have any systemic disease while taking history e.g. diabetes, hypertension
  • During pregnancy
  • History of taking analgesics 12 hours prior to treatment

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites
  • FatimaMH

    Lahore, Punjab Province, 53000

  • FatinaMH

    Lahore, Punjab Province, 53000

Other trials in Pakistan

About this study

Official title: Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth With Irreversible Pulpitis

Comparison between Naproxen and Ibuprofen in management of post operative endodontic pain was done.Total 116 patients were selected and divided in to two groups.One group was given Naproxen and other was given Ibuprofen.

Read the detailed description

This Randomized Controlled Trial was carried out in Outpatient Department of Operative Dentistry, Fatima Memorial Hospital, Lahore, Pakistan and was completed in six months from September 2nd,2019 to February 25th,2020. Sample size of 116 cases(58 in each group) of irreversible pulpitis was calculated with 80% power of test, 5% level of significance, P1(prevalence) for naproxen was 61.53% and P2 for ibuprofen is 38.46%. Estimation of P (prevalence) as 90% is based on pilot study carried in our Department. The patients were randomly allocated into two groups, A and B, by random number table. In both groups teeth were anaesthetized using 1.8ml of 2% lignocaine containing 1:100,000 epinephrine and isolated with rubber dam. An access cavity was prepared with round bur and pulpectomy was done using hand files. Working length was determined using an electronic apex locator and confirmed with periapical radiograph. Canals were prepared with step back technique. Canals were then dried with paper points and the access cavities were restored temporarily with cavit(Cavit3M ESPE).Visual analogue scale for pain score was measured for both groups before initial endodontic procedure . group A was given (naproxen 550 mg B.D), while group B was given (Ibuprofen 400mg B.D).Post-operative pain was measured subjectively after 24 hours with standard Visual Analogue Score (VAS) scored on a 10 cm scale, with markings at every 1 cm anchored by the end points of "no pain" on the left and "worst pain" on the right. Patient were asked to point the number most precisely describing the amount of pain he or she experienced after 24 hours. All this data was recorded in a specially designed proforma (attached).Efficacy was labelled as per operational definitions. Data was analyzed using SPSS version 20. For descriptive analysis, mean and standard deviation were reported for age, BMI and VAS score, whereas frequency and percentages were calculated for categorical variables like gender and educational status. A chi square was used to determine the significance of the difference between the efficacy of naproxen and ibuprofen. Data was stratified for age, gender, BMI and educational status .This comparison also included feelings of patients in terms of side effects. A p value 0.05 or less was taken as significant. Post stratification chi-square was applied with p value ≤0.05 considered as significant.

Being tested
Comparison of Efficacy of Naproxen versus Ibuprofen
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparison of Efficacy of Naproxen versus IbuprofenDrug

    Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth with Irreversible Pulpitis

Study groups in NCT04947566
Study groupRoleWhat they receive
NaproxenExperimentalin this group patients were given Naproxen
Receives: Drug: Comparison of Efficacy of Naproxen versus Ibuprofen
IbuprofenExperimentalin this group patients were given ibuprofen
Receives: Drug: Comparison of Efficacy of Naproxen versus Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. post-operative pain

    Post-operative pain was measured subjectively after 24 hours with standard Visual Analogue Score (VAS) scored on a 10 cm scale, with markings at every 1 cm anchored by the end points of "no pain" on the left and "worst pain" on the right. Patient were asked to point the number most precisely describing the amount of pain he or she experienced after 24 hours.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study start2 Sep 2019
  3. Primary completion25 Feb 2020
  4. Study completion25 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04947566
Sponsor's protocol ID
ZUsman
Status last verified
Jul 2021
First submitted
24 Jun 2021
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Comparison of Efficacy of Naproxen versus Ibuprofen in people with Pain, Postoperative, run by Fatima Memorial Hospital at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post-operative pain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

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