- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07697300
COMT, MAOA, and SLC6A4 Polymorphisms and Inferior Alveolar Nerve Block Success
The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34854
- Faculty of Dentistry, Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age between 15 and 60 years. American Society of Anesthesiologists (ASA) Physical Status I. 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. No history of systemic or genetic diseases. Ability and willingness to provide written informed consent
Exclusion Criteria:
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 hours before enrollment.
Known allergy or hypersensitivity to articaine. Presence of any systemic or genetic disease. Teeth with previous endodontic treatment. Teeth with extensive coronal destruction preventing rubber dam isolation. Presence of internal or external root resorption.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard Inferior Alveolar Nerve Block
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During root canal treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nevin kartal, Prof.Dr, Marmara University Faculty of Dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.09.2025/2025-66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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