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CompletedNCT07506265Updated Apr 6, 2026

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 Phase 4 interventional study of Dexamathsone 4mg/ml associated with experimental arm and Diclofenac Sodium (DCS) in Irreversible Pulpitis (Toothache), sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Fayoum University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled May 2025, registered Mar 2026).
Phase
Phase 4
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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).
02

Conditions studied

  • Irreversible Pulpitis (Toothache)

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Keywords

  • irreversible pulpitis
  • 4% articaine
  • buccal infiltration
  • dexamethasone
  • chymotrypsin
  • diclofenac sodium
  • mandibular molars
  • root canal
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's enrollment of 105 is above the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Systemically healthy male patients ()
  • 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

Exclusion Criteria:

  • Medically compromised patients ( 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • 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 · Drug: Diclofenac Sodium (DCS) · Drug: chymotrypsin

  • Active comparator
    articaine

    Drug: Dexamathsone 4mg/ml associated with experimental arm · Drug: Diclofenac Sodium (DCS) · Drug: chymotrypsin

Interventions

  • DrugDexamathsone 4mg/ml associated with experimental arm

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

  • 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

06

What researchers measure

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

07

Study locations

1 site
  • Faculty of dentistry, Fayoum University
    Al Fayyum, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07506265
Lead sponsor
Fayoum University
Responsible party
Mohamed Nageh (Associate professor, Fayoum University) — Principal investigator
First posted
Apr 1, 2026
Start date
May 23, 2025
Primary completion
Dec 29, 2025
Completion
Jan 1, 2026
Last update
Apr 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Diclofenac

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