Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05361291
• Other study ID #: Dexamethasone
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: August 25, 2021

Study information

• Verified date: May 2022
• Source: Jamia Millia Islamia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 25, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Lidocaine Hydrochloride
Inferior alveolar nerve block

Locations

Country	Name	City	State
India	Faculty of Dentistry, Jamia MIliia Islamia	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Jamia Millia Islamia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Rate	The effect of injections on maximum heart rates was recorded.	After 1 minutes of initial injection