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

NCT07146997 | Completed Phase 3

• 1 other identifier: Dental/HITEC/IRB/60
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Inferior Alveolar Nerve Block (IANB

  Effectiveness of Inferior Alveolar Nerve Block (IANB) Measured by the success rate of IANB in mandibular teeth with symptomatic irreversible pulpitis. Success is defined as: No pain or mild pain (VNS score 0-3) during: Access cavity preparation First file placement in the root canal Failure is defined as: Moderate to severe pain (VNS score 4-10) during the same stages. This will be compared among the four study groups (Placebo, Ibuprofen, Serratiopeptidase, and Combination therapy).

  Time Frame: Perioperative

Study Arms (4)

Group I - Placebo Group (Control)

PLACEBO COMPARATOR

Group I - Placebo: Participants will receive an oral placebo capsule identical in appearance to the active medications, administered one hour before IANB, to serve as the control group for comparison of anesthetic effectiveness

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

Group II - Ibuprofen Group

ACTIVE COMPARATOR

Group II - Ibuprofen: Participants will receive a single oral dose of ibuprofen (400 mg) administered one hour prior to IANB to evaluate its effect on improving anesthetic success in symptomatic irreversible pulpitis

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

Group III - Serratiopeptidase Group

ACTIVE COMPARATOR

Group III - Serratiopeptidase: Participants will receive a single oral dose of serratiopeptidase (10 mg) one hour before IANB to assess its effect on enhancing anesthetic efficacy in symptomatic irreversible pulpitis

Drug: Group III - Serratiopeptidase Group

Group IV - Combination Group (Ibuprofen and Serratiopeptidase)

ACTIVE COMPARATOR

Group IV - Combination (Ibuprofen and Serratiopeptidase): Participants will receive a single oral dose of ibuprofen (400 mg) and serratiopeptidase (10 mg) one hour before IANB to assess the combined effect on enhancing anesthetic success in symptomatic irreversible pulpitis

Combination Product: Group IV - Combination Group (Ibuprofen and Serratiopeptidase)

Interventions

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

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.

Group I - Placebo Group (Control)

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

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.

Group II - Ibuprofen Group

Group III - Serratiopeptidase Group DRUG

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

Group III - Serratiopeptidase Group

Group IV - Combination Group (Ibuprofen and Serratiopeptidase) COMBINATION_PRODUCT

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

Group IV - Combination Group (Ibuprofen and Serratiopeptidase)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group of subjects between 18-45 years
• Normal PDL appearance on IOPA
• No analgesics taken 12 hours prior to study
• Mandibular molars and premolars with deep carious lesion having sign and symptom of symptomatic irreversible pulpitis

You may not qualify if:

• Presence of periapical radiolucency on IOPA
• Teeth tender to percussion /traumatic teeth
• Allergy to medications/anesthetic solution
• Pregnant patient \& systemic illness
• Patient in which local anesthesia is not effective in first attempt
• Patient not giving consent

Sponsors & Collaborators

• Zahoor khan: lead
• HITEC-Institute of Medical Sciences: collaborator

Study Sites (1)

HITEC-IMS Taxila

Rawalpindi, Punjab Province, 47080, Pakistan

Location

Related Links

• As my study has not been published yet. so i have provided the related parent articleIn link above URL section just for reference \& support of the study

MeSH Terms

Interventions

Sugars; Ibuprofen; serratiopeptidase

Intervention Hierarchy (Ancestors)

Carbohydrates; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dr Zahoor Dr Zahoor khan, BDS, FCPS

  Dental college HITEC-IMS Taxila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Zahoor khan BDS FCPS

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: November 23, 2023
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: September 9, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)