NCT07697300

Brief Summary

The purpose of this study was to evaluate the association between COMT, MAOA, and SLC6A4 genetic polymorphisms and the success of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis in mandibular molars. Patients presenting with moderate to severe pain were enrolled. Before anesthesia, pain intensity was assessed using the Heft-Parker Visual Analog Scale (HP-VAS), and pulpal vitality was evaluated using cold and electric pulp tests. All participants received a standardized inferior alveolar nerve block with 4% articaine containing epinephrine. Fifteen minutes after injection, pulpal anesthesia was reassessed using cold and electric pulp tests. Patients who continued to respond to these tests were considered to have unsuccessful pulpal anesthesia and were excluded from the study. Patients with no response to either test were included in the study, and root canal treatment was initiated. Pain experienced during the procedure was assessed using the HP-VAS. Buccal swab samples were collected for genomic DNA isolation, and COMT, MAOA, and SLC6A4 polymorphisms were analyzed using a Real-Time PCR-based TaqMan genotyping assay. The association between genetic polymorphisms and the success of inferior alveolar nerve block was statistically evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 5, 2026

Last Update Submit

July 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success of Inferior Alveolar Nerve Block Anesthesia

    Anesthetic success was defined as an HP-VAS score of less than 54 mm during access cavity preparation and root canal treatment in patients with symptomatic irreversible pulpitis. An HP-VAS score of 54 mm or greater was considered anesthetic failure.

    During root canal treatment.

Study Arms (1)

Standard Inferior Alveolar Nerve Block

EXPERIMENTAL
Procedure: Inferior Alveolar Nerve Block with 4% Articaine

Interventions

A standardized inferior alveolar nerve block was administered using 4% articaine with epinephrine to patients with symptomatic irreversible pulpitis in mandibular molars. Fifteen minutes after injection, pulpal anesthesia was evaluated using cold and electric pulp tests. Participants who continued to respond to either test were considered to have unsuccessful pulpal anesthesia and were excluded from the study. Root canal treatment was initiated in participants who showed no response to both tests. Pain experienced during treatment was assessed using the Heft-Parker Visual Analog Scale (HP-VAS). Anesthetic success was defined as an HP-VAS score of less than 54 mm, whereas an HP-VAS score of 54 mm or greater was considered anesthetic failure.

Standard Inferior Alveolar Nerve Block

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 15 and 60 years. American Society of Anesthesiologists (ASA) Physical Status I. Clinical diagnosis of symptomatic irreversible pulpitis in a mandibular molar requiring primary root canal treatment.
  • Positive response to both the cold test and electric pulp test before treatment.
  • Presence of pulpal bleeding upon access cavity preparation, confirming pulp vitality.
  • Periodontal probing depth ≤3 mm. Sufficient coronal tooth structure to allow rubber dam isolation. No use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
  • No known allergy or hypersensitivity to articaine or epinephrine. No history of systemic or genetic disease. Ability and willingness to provide written informed consent.

You may not qualify if:

  • Previous endodontic treatment of the study tooth. Extensive coronal destruction preventing rubber dam isolation. Internal or external root resorption. Periodontal probing depth \>3 mm. Pregnancy or breastfeeding. Known allergy or hypersensitivity to articaine or epinephrine. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
  • Presence of any systemic or genetic disease. Inability or unwillingness to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Marmara University

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nevin kartal, Prof.Dr

    Marmara University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants received the same standardized inferior alveolar nerve block using 4% articaine with epinephrine before endodontic treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 13, 2026

Study Start

November 12, 2025

Primary Completion

April 2, 2026

Study Completion

April 28, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations