Comparison of Efficacy of Naproxen Versus Ibuprofen

NCT ID: NCT04947566

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2020-02-25

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Naproxen

in this group patients were given Naproxen

Group Type: EXPERIMENTAL

Comparison of Efficacy of Naproxen versus Ibuprofen

Intervention Type: DRUG

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

Ibuprofen

in this group patients were given ibuprofen

Group Type: EXPERIMENTAL

Comparison of Efficacy of Naproxen versus Ibuprofen

Intervention Type: DRUG

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

Interventions

Comparison of Efficacy of Naproxen versus Ibuprofen

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatima Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zarlashta Usman

ZUsman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zarlashta Usman, BDS

Role: PRINCIPAL_INVESTIGATOR

Fatima Memorial Hospital

Locations

FatimaMH

Lahore, Punjab Province, Pakistan

FatinaMH

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

ZUsman

Identifier Type: -

Identifier Source: org_study_id