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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07506265

Enrollment

105

Registered

2026-04-01

Start date

2025-05-23

Completion date

2026-01-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis (Toothache)

Keywords

irreversible pulpitis, 4% articaine, buccal infiltration, dexamethasone, chymotrypsin, diclofenac sodium, mandibular molars, root canal

Brief summary

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).

Interventions

DRUGDexamathsone 4mg/ml associated with experimental arm

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

DRUGDiclofenac Sodium (DCS)

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

DRUGchymotrypsin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026