NCT05239078

Brief Summary

Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

January 24, 2022

Last Update Submit

February 3, 2022

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (1)

  • Anesthetic 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

Study Arms (3)

Inferior Alveolar nerve block with 2% lidocaine with epinephrine

ACTIVE COMPARATOR

An inferior alveolar nerve block was given with 2% lidocaine with epinephrine

Drug: local anaesthetic injection

Inferior Alveolar nerve block with 4% articaine with epinephrine

EXPERIMENTAL

An inferior alveolar nerve block was given with 4% articaine with epinephrine

Drug: local anaesthetic injection

Inferior Alveolar nerve block with 3% plain mepivacaine

EXPERIMENTAL

An inferior alveolar nerve block was given with 3% plain mepivacaine

Drug: local anaesthetic injection

Interventions

local anaesthetic injectionDRUG

Inferior alveolar nerve block

Inferior Alveolar nerve block with 2% lidocaine with epinephrineInferior Alveolar nerve block with 3% plain mepivacaineInferior Alveolar nerve block with 4% articaine with epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active pain in a mandibular molar
  • prolonged response to cold testing with an ice stick and an electric pulp tester
  • absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
  • vital coronal pulp on access opening and ability to understand the use of pain scales

You may not qualify if:

  • known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
  • history of active peptic ulcer within the preceding 12 months
  • history of bleeding problems or anticoagulant use within the last month
  • patients who were pregnant or breast-feeding
  • a history of known or suspected drug abuse
  • patients who had taken NSAIDs within 12 h before administration of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulpitis

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 14, 2022

Study Start

March 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

February 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share