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

NCT05488925 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: BDC/ERB/2021/016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

inferior alveolar nerve block; irreversible pulpitis; diclofenac sodium; piroxicam; tramadol

Outcome Measures

Primary Outcomes (1)

• To check the efficacy of preoperative analgesics on inferior alveolar nerve block using Heft-Parker Visual Analogue Scale.

  Study's outcome is to evaluate the efficacy of different preoperative oral analgesics on inferior alveolar nerve block during root canal procedure of mandibular teeth using Heft-Parker Visual Analogue Scale on symptomatic irreversible pulpitis patients Heft-Parker Visual Analogue Scale is a visual assessment tool to record patients pain intensity. This scale is categorized as: no pain (0mm), moderate pain (55-114mm), and severe pain (\>114mm) * Patients will register their Heft-Parker Visual Analogue Scale recording to the investigator before drug ingestion * Patients will re-register their Heft-Parker Visual Analogue Scale 1 hour after the drug ingestion, during root canal procedure after inferior alveolar nerve block * The difference in the preoperative and intraoperative Heft-Parker Visual Analogue Scale score will determine the efficacy of different analgesic interventional groups

  1 hour

Study Arms (4)

Vitamin E

PLACEBO COMPARATOR

Drug: Vitamin E

Diclofenac sodium

EXPERIMENTAL

Drug: Diclofenac Sodium

Piroxicam

EXPERIMENTAL

Drug: Piroxicam

Tramadol

EXPERIMENTAL

Drug: Tramadol

Interventions

Vitamin E DRUG

Evion, 400 mg

Vitamin E

Diclofenac Sodium DRUG

Voltral SR100, 100 mg

Diclofenac sodium

Piroxicam DRUG

Feldene, 20 mg

Piroxicam

Tramadol DRUG

Tramal, 50 mg

Tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Farjad Zafar: lead

Study Sites (1)

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

Karachi, Sindh, 75340, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 21692235 RESULT

MeSH Terms

Interventions

Vitamin E; Diclofenac; Piroxicam; Tramadol

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Thiazines; Sulfur Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Farjad Zafar, BDS, MSc

  Assistant Professor and Head of Department of Dental Implantology.

  STUDY DIRECTOR

• Maryam Riaz, BDS

  Lecturer in Department of Oral Biology.

  PRINCIPAL INVESTIGATOR

• Zara Khalid, BDS

  House officer.

  PRINCIPAL INVESTIGATOR

• Tipu Sultan, BDS, MDS

  Assistant Professor in Department of Periodontology.

  PRINCIPAL INVESTIGATOR

• Aisha Wali, BDS, MPH

  Assistant Professor and Head of Department of Research and Development.

  STUDY DIRECTOR

• Talha M Siddiqui, BDS, MCPS

  Professor and Chairman of Operative Dentistry and Endodontics.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study was designed to be a double blinded study, where the operators 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor and Head of Department of Dental Implantology

Model Details: The visual analogue scale was used to assess the patients' pain levels prior to the drug ingestion. The patients were then given their respective group of drug where the control group received vitamin E and three experimental groups received one tablet/capsule of diclofenac sodium (Voltral SR100, 100 mg), piroxicam (Feldene, 20 mg), and tramadol (Tramal, 50 mg). The patients were instructed to wait for 1 hour before they were administered an inferior alveolar nerve block. Standard root canal treatment was initiated after lip numbness was achieved, and pain levels were reassessed by visual analogue scale.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: June 21, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be made available by November 2022 and will be available for 5 years till October 2027.
• Access Criteria: Researchers who have received an ethical approval from their institution/organization will be provided with the collected IPD. The data will be sent through an email.

Locations

PA (1)