Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Jordan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
Druga 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
Placebo
Other intervention2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: DXMExperimental treatment 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative pain following root canal treatment
The outcome measure is patient-reported pain following root canal treatment. Patients will be given a questionnaire to complete, on 4 different time intervals following the completion of their root canal treatment (12, 24, 48 and 72 h). For each time interval, patients will be asked to fill out: 1. their perceived pain level on a standard 100mm visual-analogue scale, with pain values ranging from zero (no pain at all) and ascending gradually until 100 (worst imagined pain). 2. Whether they needed to take any analgesics. In this case, details about the type, route, dose and timing of the analgesic taken will have to be filled out
Time frame
at 12, 24, 48 and 72 hours after completing the treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: