Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis

Comparative Evaluation of Intraligamentary Injection of Dexamethasone, Diclofenac Sodium, and Chymotrypsin for Enhancing the Success of 4% Articaine Buccal Infiltration in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

The goal of this clinical trial is to compare anesthetic success rates of intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis. Do these drugs lower the number of times participants need to be administrated with more local anesthesia? Researchers compared intraligamentary dexamethasone, diclofenac sodium, and chymotrypsin to a placebo (a look-alike substance that contains no drug) to see if interventional drugs work to achieve successful anesthesia.

• Participants were intraligamentary injected by drugs or a placebo once prior to buccal infiltration anesthesia
• Participants reported pain intensity using VAS at baseline (pre-injection), during access, and at 6, 24, 48 hours post-operative (patient diary / phone follow-up).
• Participants reported the onset time to subjective numbness (time from buccal infiltration to lip/tongue numbness).

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis (Toothache)
• Intervention / Treatment: Drug: Dexamathsone 4mg/ml associated with experimental arm; Drug: Diclofenac Sodium (DCS); Drug: chymotrypsin

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Al Fayyum, Egypt
    • Faculty of dentistry, Fayoum University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Systemically healthy male patients (ASA I or II)
• Aged 18 to 50 years
• Presenting with symptomatic irreversible pulpitis in a restorable mandibular molar
• Preoperative moderate to severe pain (VAS ≥45 mm)
• Normal periapical tissue (no radiolucency, pocket depth ≤5 mm, mobility ≤ Grade I)

Exclusion Criteria:

• Medically compromised patients (ASA III or higher)
• History of allergy or intolerance to chymotrypsin, dexamethasone, diclofenac sodium, articaine.
• Vertical root fracture
• External or internal root resorption
• Periodontal pocket depth >5 mm
• Tooth mobility Grade II or III
• Presence of periapical lesion (radiolucency)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; intraligamentary saline administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis	Drug: Dexamathsone 4mg/ml associated with experimental arm; intraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis; Drug: Diclofenac Sodium (DCS); intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis; Drug: chymotrypsin; intraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis
Active Comparator: articaine	Drug: Dexamathsone 4mg/ml associated with experimental arm; intraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis; Drug: Diclofenac Sodium (DCS); intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis; Drug: chymotrypsin; intraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anesthetic success defined as no response to thermal test, electric pulp test and lip numbness and no pain (VAS ≤ 0 or no subjective pain/stimulation response) during endodontic access and initial instrumentation without need for additional anesthesia	from anesthsesia administartion till 48 hours postoperative

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diclofenac sodium; root canal; dexamethasone; irreversible pulpitis; mandibular molars; buccal infiltration; 4% articaine; chymotrypsin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Toothache; Organic Chemicals; Carboxylic Acids; Hydrolases; Enzymes; Enzymes and Coenzymes; Acids, Carbocyclic; Endopeptidases; Peptide Hydrolases; Phenylacetates; Serine Endopeptidases; Serine Proteases; Diclofenac; Chymotrypsin
• Other Study ID Numbers: RECO6U/34-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No