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Not yet recruiting NCT06894069

Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

Early Phase I Interventional Post Operative Pain Control Endodontic Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Placebo.
Who it may be relevant to
Registry conditions: Post Operative Pain Control, Endodontic Treatment. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial

Overview

The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.

Interventions

  • Drug Dexamethasone
    a 2 ml solution of dexamethasone (3.3mg/ml) will be flushed in the root canal and intentionally extruded to the periradicular tissues to assess its potnetial sedative effect
  • Other Placebo
    2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues

Primary outcome measures

  • Post-operative pain following root canal treatment [Time frame: at 12, 24, 48 and 72 hours after completing the treatment]

Eligibility criteria

Inclusion criteria

  • A diagnosis of irreversible pulpits with symptomatic apical periodontitis
  • Adult patients (aged 18 - 70)
  • Healthy patients or those with a well-controlled disease (ASA I \& II)

Exclusion criteria

  • A diagnosis of necrotic pulp, or normal apical tissues
  • Patients with a severe systemic disease (ASA III or higher)
  • Patients who received analgesics12 hours before presentation
  • Previously treated/initiated Endodontics treatment on the same tooth
  • Unopposed teeth
  • Third molar teeth
  • Non-restorable teeth
  • Periodontally compromised teeth
  • Pregnant or lactating patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06894069 · 10/2023/ 32001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗