Symptomatic Irreversible Pulpitis (SIP)NCT07697300
COMT, MAOA, and SLC6A4 Polymorphisms and Inferior Alveolar Nerve Block Success
A study testing Inferior Alveolar Nerve Block with 4% Articaine in people with Symptomatic Irreversible Pulpitis (SIP), run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Inferior Alveolar Nerve Block with 4% Articaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2025to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Marmara University
Istanbul, Istanbul, 34854
About this study
Official title: The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block
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.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Inferior Alveolar Nerve Block with 4% Articaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block with 4% ArticaineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Inferior Alveolar Nerve Block | Experimental | Not described Receives: Procedure: Inferior Alveolar Nerve Block with 4% Articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During root canal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start12 Nov 2025
- Primary completion2 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same standardized inferior alveolar nerve block using 4% articaine with epinephrine before endodontic treatment.
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nevin kartal, Prof.Dr, Principal investigator, Marmara University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697300
- Sponsor's protocol ID
- 25.09.2025/2025-66
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between COMT, MAOA, and SLC6A4 Polymorphisms and the Success of Inferior Alveolar Nerve Block
- ClinicalTrials.gov ID
- NCT07697300
- Acronym / sponsor ID
- 25.09.2025/2025-66
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same standardized inferior alveolar nerve block using 4% articaine with epinephrine before endodontic treatment.
| Arm | Type | Receives |
|---|---|---|
| Standard Inferior Alveolar Nerve Block | Experimental | Procedure: Inferior Alveolar Nerve Block with 4% Articaine |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior Alveolar Nerve Block with 4% ArticaineA 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. | Procedure or surgery | Standard Inferior Alveolar Nerve Block |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevin kartal, Prof.Dr principal investigator
Marmara University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block with 4% Articaine in people with Symptomatic Irreversible Pulpitis (SIP), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Inferior Alveolar Nerve Block Anesthesia (time frame: During root canal treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.