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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432712
• Other study ID #: FUCDCLINIC-2404
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 10, 2024
• Est. completion date: June 10, 2025

Study information

• Verified date: May 2024
• Source: Foundation University Islamabad
• Contact: zainab butt, BDS
• Phone: +93225667847
• Email: zainabbutt05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 10, 2025
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain
• Pulpitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shoaib Rahim	Foundation University Islamabad

References & Publications (5)

Aksoy F, Ege B. The effect of pretreatment submucosal injections of tramadol and dexamethasone on post-endodontic pain in mandibular molar teeth with symptomatic irreversible pulpitis: a randomized controlled clinical trial. Int Endod J. 2020 Feb;53(2):17 — View Citation

Nogueira BML, Silva LG, Mesquita CRM, Menezes SAF, Menezes TOA, Faria AGM, Porpino MTM. Is the Use of Dexamethasone Effective in Controlling Pain Associated with Symptomatic Irreversible Pulpitis? A Systematic Review. J Endod. 2018 May;44(5):703-710. doi: — View Citation

Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatm — View Citation

Yavari HR, Jafari F, Jamloo H, Hallaj-Nezhadi S, Jafari S. The Effect of Submucosal Injection of Corticosteroids on Pain Perception and Quality of Life after Root Canal Treatment of Teeth with Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2 — View Citation

Yeganegi S, Fazelian N, Layegh Nejad MK, Manzouri L. Comparison of the Efficacy of Dexamethasone and Methylprednisolone in Infiltration Injection for Postendodontic Pain in Patients with Necrotic Pulp: A Randomized Controlled Clinical Trial. Pain Res Mana — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post operative pain	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.	12 hours, 24 hours and 1 week