Comparison of Efficacy of Naproxen Versus Ibuprofen
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Comparison of Efficacy of Naproxen versus Ibuprofen
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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
Sites / Locations
- FatimaMH
- FatinaMH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Naproxen
Ibuprofen
Arm Description
in this group patients were given Naproxen
in this group patients were given ibuprofen
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04947566
Brief Title
Comparison of Efficacy of Naproxen Versus Ibuprofen
Official Title
Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth With Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen
Arm Type
Experimental
Arm Description
in this group patients were given Naproxen
Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
in this group patients were given ibuprofen
Intervention Type
Drug
Intervention Name(s)
Comparison of Efficacy of Naproxen versus Ibuprofen
Intervention Description
Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth with Irreversible Pulpitis
Primary Outcome Measure Information:
Title
post-operative pain
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zarlashta Usman, BDS
Organizational Affiliation
Fatima Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
FatimaMH
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53000
Country
Pakistan
Facility Name
FatinaMH
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53000
Country
Pakistan
12. IPD Sharing Statement
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