Evaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block Effectiveness

Summary

This clinical study investigates whether the combination of ibuprofen and serratiopeptidase as oral premedication can enhance the effectiveness of the inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular teeth. Due to the inflammatory nature of the condition, standard IANB often fails, possibly due to prostaglandin-induced nerve sensitization.

A total of 96 patients meeting specific inclusion criteria will be divided into four groups:

Placebo

Ibuprofen alone

Serratiopeptidase alone

Combination of ibuprofen and serratiopeptidase

Pain levels will be measured using the Verbal Numerical Scale (VNS) at various treatment stages. The success of anesthesia will be determined by the absence or presence of pain during access cavity preparation and initial root canal instrumentation. Statistical analysis will compare the effectiveness between groups, with the goal of determining whether combined premedication significantly improves IANB success.

The study is conducted at the Department of Operative Dentistry \& Endodontics, HITEC-IMS Taxila, over a period of six months.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

DIETARY_SUPPLEMENT

Patients in this group will receive an oral placebo (e.g., sugar tablet or inert capsule) 1 hour before the IANB

Group I - Placebo Group (Control) Intervention: Patients in this group will receive an oral placebo (e.g., sugar tablet or inert capsule) 1 hour before the IANB. Purpose: This group serves as the control to establish a baseline anesthetic success rate without active premedication. Expected Outcome: Lower IANB success rate due to lack of anti-inflammatory intervention.

DRUG

Patients will receive ibuprofen (400-600 mg, standard therapeutic dose) orally, 1 hour prior to IANB

Group II - Ibuprofen Group Intervention: Patients will receive ibuprofen (400-600 mg, standard therapeutic dose) orally, 1 hour prior to IANB. Purpose: Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and inflammation, which can enhance anesthetic efficacy. Expected Outcome: Improved IANB success rate compared to placebo, but possibly lower than combination therapy.

DRUG

Group III - Serratiopeptidase Group

Group III - Serratiopeptidase Group Intervention: Patients will receive serratiopeptidase (10 mg or standard dose) orally, 1 hour before the IANB. Purpose: Serratiopeptidase is a proteolytic enzyme with anti-inflammatory, mucolytic, and fibrinolytic properties. It helps reduce tissue inflammation by breaking down inflammatory mediators and possibly inhibiting prostaglandin production. Expected Outcome: Improved IANB success rate compared to placebo; effectiveness may vary compared to ibuprofen alone

COMBINATION_PRODUCT

Group IV - Combination Group (Ibuprofen and Serratiopeptidase)

Group IV - Combination Group (Ibuprofen and Serratiopeptidase) Intervention: Patients will receive a combination of ibuprofen and serratiopeptidase orally, 1 hour before IANB. The doses will be the same as those used in Groups II and III, respectively. Purpose: This group is designed to test the synergistic effect of combining an NSAID (ibuprofen) and a proteolytic enzyme (serratiopeptidase) to maximize inflammation control and increase the success of IANB in inflamed pulp tissue. Expected Outcome: Highest success rate of IANB due to dual action on prostaglandin inhibition and tissue inflammation reduction

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences

  collaborator OTHER

• Zahoor khan

  lead OTHER

Principal Investigators

• Dr Zahoor Dr Zahoor khan, BDS, FCPS · Dental college HITEC-IMS Taxila

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-23

Primary Completion

2024-11-23

Completion

2024-11-23

Countries

• Pakistan

Study Locations