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.
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
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.
- Conditions
- Pain, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| Naproxen | Experimental | in this group patients were given Naproxen Receives: Drug: Comparison of Efficacy of Naproxen versus Ibuprofen |
| Ibuprofen | Experimental | in 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.
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.
- First posted1 Jul 2021
- Study start2 Sep 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zarlashta Usman, Fatima Memorial Hospital
- Investigators
- Zarlashta Usman, BDS, Principal investigator, Fatima Memorial Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT04947566
- Acronym / sponsor ID
- ZUsman
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Experimental | Drug: Comparison of Efficacy of Naproxen versus Ibuprofenin this group patients were given Naproxen |
| Ibuprofen | Experimental | Drug: Comparison of Efficacy of Naproxen versus Ibuprofenin this group patients were given ibuprofen |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Age range 20-40 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of Efficacy of Naproxen versus IbuprofenComparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth with Irreversible Pulpitis | Drug | Ibuprofen, Naproxen |
Primary outcome
post-operative pain
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zarlashta Usman, BDS principal investigator
Fatima Memorial Hospital
2 sites in 1 country: see every site and its status.
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.