Preoperative Dexamethasone Injection to Improve Local Anesthesia Success in Endodontic Treatment

NCT07699315 | Not Yet Recruiting Phase 4

• 1 other identifier: WMDC/R&D(ERB)/2024/157
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Symptomatic Irreversible Pulpitis; Dexamethasone; Root canal Treatment; Intraoperative pain; Endodontics; local anesthesia; Inferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

Participants receive dexamethasone as an adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis

Drug: dexamethasone

Saline

PLACEBO COMPARATOR

participants receive normal saline as a placeb adjunct to local anesthesia before endodontic treatment for symptomatic irreversible pulpitis

Drug: Saline (0.9% NaCl)

Interventions

dexamethasone DRUG

participants receive 4mg dexamethasone administered via intraligamental infiltration followed by inferior alveolar nerve block before endodontic treatment of mandibular molars with symptomatic irreversible pulpitis

Dexamethasone Group

Saline (0.9% NaCl) DRUG

participants receive an equivalent volume of normal saline administered via intraligamental infiltration before root canal treatment for symptomatic irreversible pulpitis

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Watim Medical & Dental College: lead

MeSH Terms

Interventions

Dexamethasone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dr.Ayesha S Janjua, BDS

  Watim Medical and Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayesha S Janjua, BDS

CONTACT

+92 321 5252096; ashsarwar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Operative Dentistry and Endodontics

Model Details: This is a prospective ,randomized, placebo controlled , parallel-group clinical trial evaluating the effect of preoperative intraligamentary dexamethasone injection on the anesthetic success of 2% lidocaine during endodontic treatment of mandibular molars with symptomatic irreversible pulpitis . Sixty participants will be randomly allocated to receive either dexamethasone (4mg/ml) or sterile normal saline before inferior alveolar nerve block. The primary outcome is anesthetic success , defined as pain-free endodontic treatment without the need for supplemental anesthesia.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share