NCT06342869

Brief Summary

Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis. Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

February 28, 2024

Last Update Submit

March 29, 2024

Conditions

Keywords

articaine, lidocaine, irreversible pulpitis, infiltration anesthesia

Outcome Measures

Primary Outcomes (1)

  • Assessment of complementary palatinal anesthesia with VAS

    10 minutes after anesthesia is performed

Study Arms (4)

buccal infiltration with 4% articaine containing 1:100,000 epinephrine

EXPERIMENTAL
Procedure: Anesthesia

buccal infiltration with 2% lidocaine containing 80,000 epinephrine

EXPERIMENTAL
Procedure: Anesthesia

buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine

EXPERIMENTAL
Procedure: Anesthesia

buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine

EXPERIMENTAL
Procedure: Anesthesia

Interventions

AnesthesiaPROCEDURE

application of different anesthesia techniques

buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrinebuccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrinebuccal infiltration with 2% lidocaine containing 80,000 epinephrinebuccal infiltration with 4% articaine containing 1:100,000 epinephrine

Eligibility Criteria

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

You may qualify if:

  • The patient must be a healthy individual between the ages of 18 and 65 who is classified as ASA I and II.
  • No allergy to local anesthetic substances to be used in the study
  • Upper maxillary molars with irreversible pulpitis whose vitality has been proven by pulp tests, with no radiolucency at the root tip
  • Not having used any painkillers, antibiotics, antidepressants and sedative drugs in the last 12 hours
  • Being capable of understanding the Pain scale

You may not qualify if:

  • Allergy to local anesthetics
  • Failure to respond to the cold test and electric pulp test performed on the relevant tooth
  • Radiolucent lesion in the apical part of the relevant tooth on periapical radiography
  • No vital tissue is encountered when the pulp chamber is opened

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

  • Kanaa MD, Whitworth JM, Meechan JG. A comparison of the efficacy of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:80,000 epinephrine in achieving pulpal anesthesia in maxillary teeth with irreversible pulpitis. J Endod. 2012 Mar;38(3):279-82. doi: 10.1016/j.joen.2011.11.010. Epub 2011 Dec 22.

    PMID: 22341059BACKGROUND
  • Kolay D, Kirici D. Comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in maxillary molars with irreversible pulpitis: a prospective randomized study. BMC Oral Health. 2025 Feb 8;25(1):207. doi: 10.1186/s12903-025-05552-y.

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 28, 2024

First Posted

April 2, 2024

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations