Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

NCT05361291 | Completed

• 1 other identifier: Dexamethasone
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (1)

• Anesthtic success

  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.

  15 minutes after the inferior alveolar nerve block

Secondary Outcomes (1)

• Heart Rate

  After 1 minutes of initial injection

Study Arms (3)

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

ACTIVE COMPARATOR

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

Drug: Lidocaine Hydrochloride

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

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride

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

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride

Interventions

Lidocaine Hydrochloride DRUG

Inferior alveolar nerve block

Also known as: dexamethasone

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

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jamia Millia Islamia: lead

Study Sites (1)

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

Location

MeSH Terms

Interventions

Lidocaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: February 1, 2020
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately after publication
• Access Criteria: Immediately after publication

Locations

IN (1)