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Completed

NCT Number: NCT07697300

COMT, MAOA, and SLC6A4 Polymorphisms and Inferior Alveolar Nerve Block Success

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.

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Marmara University

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Inferior Alveolar Nerve Block with 4% Articaine

Procedure

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.

Primary outcomes

  1. Success of Inferior Alveolar Nerve Block Anesthesia

    Time frame: During root canal treatment.

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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