Preoperative Dexamethasone Injection to Improve Local Anesthesia Success in Endodontic Treatment (DILAS)

Preoperative Intraligamentary Injection of Dexamethasone Can Improve the Anesthetic Success Rate of 2% Lidocaine During the Endodontic Management of Mandibular Molars With Symptomatic Irreversible Pulpitis

This study aims to determine whether giving a single dose of 4mg dexamethasone before root canal treatment can reduce the amount of pain patients experience during the procedure . Patients diagnosed with symptomatic Irreversible Pulpitis requiring endodontic treatment will be enrolled. Participants will receive either dexamethasone or placebo before treatment , and pain during the procedure will be measured using a Visual Analogue Scale (VAS) .

The findings may help improve pain management strategies during root canal treatment .

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: dexamethasone; Drug: Saline (0.9% NaCl)

Detailed Description

Symptomatic irreversible pulpitis is a common cause of severe dental pain, and achieving adequate pain control during endodontic treatment remains a challenge despite the use of local anesthesia. Inflammatory mediators present in inflamed pulp tissues may reduce the effectiveness of local anesthetics , resulting in persistent intraoperative pain.

Dexamethasone is a corticosteroid with potent anti-inflammatory properties that may reduce inflammatory mediator release and improve pain control . This randomized controlled clinical trial aims to evaluate the effectiveness of preoperative 4mg dose of dexamethasone compared with placebo in reducing intraoperative pain during endodontic treatment of teeth diagnosed with symptomatic irreversible pulpitis.

Eligible participants will be randomly allocated to receive either dexamethasone or placebo before treatment . Standard local anesthesia and endodontic procedures will be performed for all participants .

Intraoperative pain intensity will be assessed using a Visual Analogue Scale. The primary outcome will be the difference in intraoperative pain scores between the two groups.

The results of this study may provide evidence regarding the role of preoperative dexamethasone as an adjunct for improving pain control during endodontic treatment .

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ayesha S Janjua, BDS; Phone Number: +92 321 5252096; Email: ashsarwar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with pain VAS >/= 6
2. Carious exposed mandibular molar with symptomatic irreversible pulpitis
3. Patients between ages 18-60 years
4. American Society of Anesthesiologists class I or II medical histories -

Exclusion Criteria:

1. Patients with contraindications to local anesthesia solution or dexamethasone 2.Pregnant or breast-feeding females 4.Tooth having fused/extra roots, full coverage crowns, or poor periodontal status 5. Patients taking drugs which could affect the pain perception

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexamethasone Group; Participants receive dexamethasone as an adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis	Drug: dexamethasone; participants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis
Placebo Comparator: Saline; participants receive normal saline as a placeb adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis	Drug: Saline (0.9% NaCl); participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pain intensity	intraoperative pain intensity measured using the Heft-parker Visual Analogue Scale following root canal treatment	Pain intensity assessed intraoperatively from initiation of access cavity preparation until completion of canal instrumentation during a single visit ( approximately 30-90 minutes).

Collaborators and Investigators

• Sponsor: Watim Medical & Dental College
• Investigators: Principal Investigator: Dr.Ayesha S Janjua, BDS, Watim Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Dexamethasone; local anesthesia; Endodontics; Intraoperative pain; Inferior Alveolar Nerve Block; Symptomatic Irreversible Pulpitis; Root canal Treatment
• Additional Relevant MeSH Terms: Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Sodium Compounds; Chlorides; Hydrochloric Acid; Dexamethasone; Sodium Chloride
• Other Study ID Numbers: WMDC/R&D(ERB)/2024/157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No