Comparison of Post Operative Endodontic Pain in Patients with Irreversible Pulpitis Treated with and Without Dexamethasone.

Shoaib Rahim

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Pain

Treatments: Drug: Dexamethasone 4mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06432712

FUCDCLINIC-2404

Details and patient eligibility

About

Root canal procedure is a common procedure in dentistry. Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain.

Potential Solution: The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain.

Research Goal: Pain score of patients treated with dexamethasone infiltration will be less compared to patients treated with NSAIDS alone after canal instrumentation.

Full description

Acute inflammatory response in peri-radicular tissues after root canal treatment is the main cause of post op pain. The peak inflammatory response occurs after 24 - 48 hours of root canal instrumentation. As management of post-endodontic pain is still a challenge for clinicians several drugs which include NSAIDs, acetaminophen, opioids and steroids are used to reduce the inflammatory response. Corticosteroids possess anti-inflammatory efficacy, and they prevent the production and release of inflammatory mediators at the site of tissue injury thus reducing the signs & symptoms of inflammation such as pain, swelling & loss of function. Dexamethasone is a potent corticosteroid that has the ability to reduce the production of proinflammatory cytokines. Dexamethasone can be administered orally, or as an intraosseous, intra ligament periapical & intracanal injection. Dexamethasone is effective in alleviating pain in first 24 hours post endodontic treatment. Previous research on the effect of dexamethasone injection on post-endodontic treatment pain in patients presenting with necrotic pulp treated with single visit endodontic treatment reported 25% post operative pain occurrence and 9% when treated with dexamethasone.

Study Goal : The current study will assess effect of dexamethasone administered as periapical infiltration in reducing post-instrumentation pain as compared to the prescription of NSAIDs only. If dexamethasone infiltration is effective in pain relief after endodontic treatment, it can be a useful adjunct in managing patients presenting with acute pulpal pain.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients of age 18-50 years
• Maxillary molar and premolar teeth
• Pt diagnosed with irreversible pulpitis with or without apical periodontitis

Exclusion criteria

• Teeth with calcified canals.
• Teeth with incompletely formed apices.
• Teeth requiring retreatment.
• Taking analgesics, anti-inflammatory, or tri-cyclic anti-depressants for their medical conditions.
• Teeth with grade II or III mobility (more than 2 mm)
• Pregnant patients
• Pt who are immunocompromised (uncontrolled diabetes mellitus, renal impairment)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in this arm will receive routine root canal treatment with a prescription of NSAIDs post operatively.

Experimental

Experimental group

Description:

Participants in this arm will receive routine root canal treatment along with 2.5ml of dexamethasone 4mg/ml peri apical infiltration with a prescription of NSAIDs post operatively.

Treatment:

Drug: Dexamethasone 4mg