Skip to main content
Clinical Trials/NCT05361291
NCT05361291
Completed
Not Applicable

Comparative Evaluation of Adding Dexamethasone to 2% Lidocaine (With and Without Epinephrine) on the Anesthetic Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

Jamia Millia Islamia1 site in 1 country124 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Lidocaine Hydrochloride
Conditions
Pulpitis - Irreversible
Sponsor
Jamia Millia Islamia
Enrollment
124
Locations
1
Primary Endpoint
Anesthtic success
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis. One hundred and twenty four patients received one of the three IANB injections before the endodontic treatment: 2% lidocaine with 1:80 000 epinephrine; 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone; and plain 2% lidocaine mixed with 2mg dexamethasone. The anesthetia was considered successful if the patients experienced no pain or faint/weak/mild pain during root canal access preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary injections on maximum heart rates was also recorded.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
August 25, 2021
Last Updated
3 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

  • absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
  • active pain in a mandibular molar
  • prolonged response to cold testing with an ice stick and an electric pulp tester
  • vital coronal pulp on access opening and ability to understand the use of pain scales

Exclusion Criteria

  • a history of known or suspected drug abuse
  • history of active peptic ulcer within the preceding 12 months
  • history of bleeding problems or anticoagulant use within the last month
  • known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
  • patients who had taken NSAIDs within 12 h before administration of the study drugs
  • patients who were pregnant or breast-feeding

Arms & Interventions

Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine

An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine

Intervention: Lidocaine Hydrochloride

Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone

An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone

Intervention: Lidocaine Hydrochloride

Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone

An Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone

Intervention: Lidocaine Hydrochloride

Outcomes

Primary Outcomes

Anesthtic success

Time Frame: 15 minutes after the inferior alveolar nerve block

Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.

Secondary Outcomes

  • Heart Rate(After 1 minutes of initial injection)

Study Sites (1)

Loading locations...

Similar Trials