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

NCT ID: NCT06432712

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-06-10

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Postoperative Pain Root canal therapy Dexamethasone Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Dexamethasone 4mg

Intervention Type DRUG

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

Interventions

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Dexamethasone 4mg

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation University Islamabad

OTHER

Sponsor Role collaborator

Shoaib Rahim

OTHER

Sponsor Role lead

Responsible Party

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Shoaib Rahim

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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zainab butt, BDS

Role: CONTACT

Phone: +93225667847

Email: [email protected]

Rozina Nazir, FCPS

Role: CONTACT

Phone: +92 3215376612

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 32976660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35251416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31702056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29571913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30910353 (View on PubMed)

Other Identifiers

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FUCDCLINIC-2404

Identifier Type: -

Identifier Source: org_study_id