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Completed

NCT Number: NCT07506265

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

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).

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Key information

Conditions

Irreversible Pulpitis (Toothache) Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, Fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexamathsone 4mg/ml associated with experimental arm

Drug

intraligamentary dexamethasone administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

Diclofenac Sodium (DCS)

Drug

intraligamentary diclofenac sodium administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

Chymotrypsin

Drug

intraligamentary chymotrypsin administered prior to buccal 4% articaine infiltration in mandibular molars with symptomatic irreversible pulpitis

Primary outcomes

  1. 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

    Time frame: from anesthsesia administartion till 48 hours postoperative

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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