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Clinical Trials/NCT06432712
NCT06432712
Not yet recruiting
Early Phase 1

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

Shoaib Rahim0 sites140 target enrollmentJanuary 10, 2025
ConditionsPain
InterventionsDexamethasone 4mg

Overview

Phase
Early Phase 1
Intervention
Dexamethasone 4mg
Conditions
Pain
Sponsor
Shoaib Rahim
Enrollment
140
Primary Endpoint
post operative pain
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 10, 2025
End Date
June 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shoaib Rahim
Responsible Party
Sponsor Investigator
Principal Investigator

Shoaib Rahim

Assistant professor

Foundation University Islamabad

Eligibility Criteria

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)

Arms & Interventions

Experimental

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.

Intervention: Dexamethasone 4mg

Outcomes

Primary Outcomes

post operative pain

Time Frame: 12 hours, 24 hours and 1 week

The patient's pain response before treatment will be recorded using visual analogue scale 0-10.Pain score of 3 and less than 3 will be categorized as no postoperative pain and score greater than 3 will be categorized as post operative pain.

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