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

PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

November 23, 2023

Primary Completion Date

November 23, 2024

Study Completion Date

November 23, 2024

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"

Trial Locations (1)

47080

HITEC-IMS Taxila, Rawalpindi

All Listed Sponsors
collaborator

HITEC-Institute of Medical Sciences

OTHER

lead

Zahoor khan

OTHER

NCT07146997 - Evaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block Effectiveness | Biotech Hunter | Biotech Hunter