Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-08-25

Brief Summary

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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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Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type DRUG

Inferior alveolar nerve block

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

Group Type EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type DRUG

Inferior alveolar nerve block

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

Group Type EXPERIMENTAL

Lidocaine Hydrochloride

Intervention Type DRUG

Inferior alveolar nerve block

Interventions

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Lidocaine Hydrochloride

Inferior alveolar nerve block

Intervention Type DRUG

Other Intervention Names

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dexamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes