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

NCT06432712 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: FUCDCLINIC-2404
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Postoperative Pain; Root canal therapy; Dexamethasone; Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Experimental

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.

Drug: Dexamethasone 4mg

Interventions

Dexamethasone 4mg DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shoaib Rahim: lead
• Foundation University Islamabad: collaborator

Related Publications (5)

• 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 treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.

  PMID: 32976660 BACKGROUND

• 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 Manag. 2022 Feb 23;2022:4163120. doi: 10.1155/2022/4163120. eCollection 2022.

  PMID: 35251416 BACKGROUND

• 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):176-185. doi: 10.1111/iej.13246. Epub 2019 Nov 28.

  PMID: 31702056 BACKGROUND

• 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: 10.1016/j.joen.2018.02.006. Epub 2018 Mar 20.

  PMID: 29571913 BACKGROUND

• 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. 2019 May;45(5):477-482. doi: 10.1016/j.joen.2019.01.005. Epub 2019 Mar 23.

  PMID: 30910353 BACKGROUND

MeSH Terms

Conditions

Pain; Pain, Postoperative; Pulpitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

zainab butt, BDS

CONTACT

+93225667847; zainabbutt05@gmail.com

Rozina Nazir, FCPS

CONTACT

+92 3215376612; rozina.nazir@fui.edu.pk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: January 10, 2025
• Primary Completion: January 10, 2025
• Study Completion: June 10, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share