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Completed

NCT Number: NCT05361291

Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine Hydrochloride

Drug

Inferior alveolar nerve block

Other names: dexamethasone

Primary outcomes

  1. 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

  1. Heart Rate

    Time frame: After 1 minutes of initial injection

    The effect of injections on maximum heart rates was recorded.

Sponsors and collaborators

Lead sponsor

Jamia Millia Islamia

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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