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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06432712
Enrollment
140
Registered
2024-05-29
Start date
2025-01-10
Completion date
2025-06-10
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Postoperative Pain, Root canal therapy, Dexamethasone, Pulpitis

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.

Interventions

DRUGDexamethasone 4mg

2.5ml of Dexamethasone 4mg/ml will be administered via periapical infiltration with a 23 gauge needle to the experimental group.

Sponsors

Foundation University Islamabad
CollaboratorOTHER
Shoaib Rahim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
post operative pain12 hours, 24 hours and 1 weekThe 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.

Contacts

Primary Contactzainab butt, BDS
zainabbutt05@gmail.com+93225667847
Backup ContactRozina Nazir, FCPS
rozina.nazir@fui.edu.pk+92 3215376612

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026