Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.

NCT ID: NCT05488925

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2022-02-18

Brief Summary

The purpose of this study is to see how preoperative oral diclofenac sodium, piroxicam, and tramadol affects inferior alveolar nerve block efficacy during root canal treatment of mandibular molars with symptomatic irreversible pulpitis.

The proposed hypothesis is that the tested drug groups will improve the efficacy of inferior alveolar nerve block in comparison to the control group.

Detailed Description

Standard Operating Procedure:

• A non-probability consecutive sampling was done in a dental out patient department and 120 patients were included and randomly divided in the 4 groups (n=30) using simple randomization as per the inclusion criteria.
• A verbal informed consent was taken from each participant before including them in a group.
• The study was designed to be a double blinded study, where the researchers and the patients both were unaware of the groups of drugs that were used; this anonymity was achieved by marking the groups A, B, C and D on boxes for drugs containing a placebo, diclofenac sodium, piroxicam, and tramadol respectively.
• The Heft Parker Visual Analogue Scale was used to assess the patients' pain levels prior to the drug ingestion, and the study was continued on the patients that reported moderate to severe pain on the Visual Analogue Scale. On this scale, the pain intensities were categorized as: no pain (0), mild pain (1-54 mm), moderate pain (55- 114 mm) and severe pain (> 114 mm).
• The patients were then given their respective group of drug/placebo. The patients were instructed to wait for 1 hour before they were administered Inferior Alveolar Nerve Block with 1.8 ml of 2% lidocaine with 1:100000 epinephrine using a non-aspirating syringe through a long needle of 27-Gauge.
• Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by Heft Parker Visual Analogue Scale during the root canal procedure. However, the patients who did not achieve the numbness of the lips were excluded from the study.
• Patients who reported discomfort and pain during the endodontic procedure were intervened appropriately; conversely, if the patient did not report any intraoperative pain, endodontic procedure was resumed.
• Till the end of the data collection process, the collected data forms were stored in a 4 different files labeled A ,B ,C and D respective to the drug groups. On completion of the collection process the data was added and stored as a data file into IBM SPSS Statistics version 25 and further analyzed.

Sample Size Estimation:

The study size was calculated with reference to previous reports, revealing that at least 30 individuals should be included as per the analysis of power of the study. The value of power used was 0.96, the effect size was taken as 0.4, and α was set as 0.05.

Statistical Analysis Plan:

Test of normality will be checked using one sample Shapiro Wilk. One-way ANOVA with Tukey's post-hoc will be employed if parametric test criteria is met; however if the parametric criteria is not fulfilled, the experimental groups will be compared using Kruskal-Wallis test with post-hoc analysis. The Chi-square test will be used to compare gender and drug groups against the Inferior Alveolar Nerve Block efficacy. These tests will be conducted on SPSS Statistics version 25.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

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

Study Groups

Vitamin E

Group Type: PLACEBO_COMPARATOR

Vitamin E

Intervention Type: DRUG

Evion, 400 mg

Diclofenac sodium

Group Type: EXPERIMENTAL

Diclofenac Sodium

Intervention Type: DRUG

Voltral SR100, 100 mg

Piroxicam

Group Type: EXPERIMENTAL

Piroxicam

Intervention Type: DRUG

Feldene, 20 mg

Tramadol

Group Type: EXPERIMENTAL

Tramadol

Intervention Type: DRUG

Tramal, 50 mg

Interventions

Vitamin E

Evion, 400 mg

Intervention Type: DRUG

Diclofenac Sodium

Voltral SR100, 100 mg

Intervention Type: DRUG

Piroxicam

Feldene, 20 mg

Intervention Type: DRUG

Tramadol

Tramal, 50 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients between the ages of 18 - 65 years.
• Patients with no medical or systemic conditions.
• Patients with prolonged pain response on cold pulp testing of 1st and 2nd mandibular molars.
• Patient with 1st and 2nd mandibular molars having symptomatic irreversible pulpitis with no periapical pathology or tenderness on percussion.
• Preoperative moderate to severe pain on heft parker visual analogue scale.
• Patients who can understand the recording of the pain using heft parker visual analogue scale.

Exclusion Criteria

• Patients who are pregnant and/or breastfeeding.
• Patients with reported allergy to diclofenac sodium, piroxicam, and tramadol.
• Patients with periodontal pathologies, necrotized pulp, ankylosed or resorbed roots, open apex and non-restorable tooth.
• Patients who have taken an analgesic in the past 24 hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Farjad Zafar

OTHER

Sponsor Role: lead

Responsible Party

Farjad Zafar

Assistant Professor and Head of Department of Dental Implantology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Farjad Zafar, BDS, MSc

Role: STUDY_DIRECTOR

Assistant Professor and Head of Department of Dental Implantology.

Maryam Riaz, BDS

Role: PRINCIPAL_INVESTIGATOR

Lecturer in Department of Oral Biology.

Zara Khalid, BDS

Role: PRINCIPAL_INVESTIGATOR

House officer.

Tipu Sultan, BDS, MDS

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor in Department of Periodontology.

Aisha Wali, BDS, MPH

Role: STUDY_DIRECTOR

Assistant Professor and Head of Department of Research and Development.

Talha M Siddiqui, BDS, MCPS

Role: STUDY_CHAIR

Professor and Chairman of Operative Dentistry and Endodontics.

Locations

Department of Operative Dentistry, Baqai Dental College, Baqai Medical University.

Karachi, Sindh, Pakistan

Countries

Pakistan

References

Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.

Reference Type: RESULT

PMID: 21692235 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BDC/ERB/2021/016

Identifier Type: -

Identifier Source: org_study_id