Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Not Applicable

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Lidocaine Hydrochloride

• Registration Number: NCT05361291
• Lead Sponsor: Jamia Millia Islamia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-08-25
• Study Completion: 2021-08-25
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Status Verified: 2022-05
• Study First Posted: 2022-05-04
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone	Lidocaine Hydrochloride	An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone
Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine	Lidocaine Hydrochloride	An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine
Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone	Lidocaine Hydrochloride	An Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone

Primary Outcome Measures

Name	Time	Method
Anesthtic success	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 Outcome Measures

Name	Time	Method
Heart Rate	After 1 minutes of initial injection	The effect of injections on maximum heart rates was recorded.

Trial Locations

Locations (1)

Faculty of Dentistry, Jamia MIliia Islamia; 🇮🇳 New Delhi, India