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Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lidocaine Hydrochloride
Sponsored by
Jamia Millia Islamia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, Jamia MIliia Islamia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heart Rate
The effect of injections on maximum heart rates was recorded.

Full Information

First Posted
April 29, 2022
Last Updated
May 4, 2022
Sponsor
Jamia Millia Islamia
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1. Study Identification

Unique Protocol Identification Number
NCT05361291
Brief Title
Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
August 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jamia Millia Islamia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine
Arm Type
Active Comparator
Arm Description
An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine
Arm Title
Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone
Arm Type
Experimental
Arm Description
An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone
Arm Title
Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone
Arm Type
Experimental
Arm Description
An Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
dexamethasone
Intervention Description
Inferior alveolar nerve block
Primary Outcome Measure Information:
Title
Anesthtic success
Description
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.
Time Frame
15 minutes after the inferior alveolar nerve block
Secondary Outcome Measure Information:
Title
Heart Rate
Description
The effect of injections on maximum heart rates was recorded.
Time Frame
After 1 minutes of initial injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Dentistry, Jamia MIliia Islamia
City
New Delhi
ZIP/Postal Code
110025
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Access Criteria
Immediately after publication

Learn more about this trial

Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine

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