Clinical trial

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

Name
FUCDCLINIC-2404
Description
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.
Trial arms
Trial start
2024-06-10
Estimated PCD
2025-01-10
Trial end
2025-06-10
Status
Not yet recruiting
Phase
Early phase I
Treatment
Dexamethasone 4mg
2.5ml of Dexamethasone 4mg/ml will be administered via periapical infiltration with a 23 gauge needle to the experimental group.
Arms:
Experimental
Size
140
Primary endpoint
post operative pain
12 hours, 24 hours and 1 week
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive dexamethasone infiltration or only analgesic therapy. They will remain in their assigned group throughout the study.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}
Updated at
2024-05-29

1 organization

1 product

1 indication

Organization
Shoaib Rahim
Indication
Pain