Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

University of Jordan

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Post Operative Pain Control; Endodontic Treatment

Treatments: Drug: Dexamethasone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06894069

10/2023/ 32001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

DXM

Experimental group

Description:

Patients in this group will receive a standard root canal treatment but with the extra step of extruding a Dexamethasone (DXM) solution through the root canals to the periradicular tissues prior to obturation.

Treatment:

Drug: Dexamethasone

Saline

Placebo Comparator group

Description:

Patients in this group will receive a standard root canal treatment with saline used as the final irrigating solution prior to obturation.

Treatment:

Other: Placebo