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Clinical Trials/NCT06186921
NCT06186921
Recruiting
Not Applicable

Effect of Different Intraligamentary Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis

Jamia Millia Islamia1 site in 1 country140 target enrollmentDecember 2, 2023
ConditionsPulpitis
InterventionsDexamethasone

Overview

Phase
Not Applicable
Intervention
Dexamethasone
Conditions
Pulpitis
Sponsor
Jamia Millia Islamia
Enrollment
140
Locations
1
Primary Endpoint
Post operative pain
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.

Detailed Description

The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.

Registry
clinicaltrials.gov
Start Date
December 2, 2023
End Date
March 3, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Vivek Aggarwal

Professor

Jamia Millia Islamia

Eligibility Criteria

Inclusion Criteria

  • Symptomatic carious exposed mandibular first or second molars.
  • Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
  • Vital coronal pulp on access cavity preparation.
  • American Society of Anesthesiologists class I or II medical history.
  • Ability to understand the use of pain scales.

Exclusion Criteria

  • Active pain in more than 1 tooth
  • Teeth with fused roots.
  • Radiographic evidence of an extra root.
  • Large restorations with overhanging margins.
  • Full crowns or deep periodontal pockets.
  • Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
  • History of known or suspected drug abuse.
  • Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
  • Pregnant or breastfeeding patients.
  • Patients with asthma, gastric ulcers, and bleeding disorders.

Arms & Interventions

Intraligamentary injection of dexamethasone

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Intervention: Dexamethasone

Intraligamentary injection of diclofenac sodium

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Intervention: Dexamethasone

Intraligamentary injection of 0.5% bupivacaine

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Intervention: Dexamethasone

Intraligamentary injection of 2% lidocaine

After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone

Intervention: Dexamethasone

Outcomes

Primary Outcomes

Post operative pain

Time Frame: 2 hours, 6 hours, 24 hours and 72 hours after treatment

The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.

Study Sites (1)

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