Mandibular NerveNCT06679660
Comparative Assessment of Mental/Incisive and Inferior Alveolar Nerve Block Anesthesia in Root Canal Treatment of Mandibular Premolars
A study testing inferior alveolar nerve block with 4% articaine and Mental/Incisive Nerve Block (%4 Articaine) in people with Mandibular Nerve and Mandibular Nerve Blocks, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Nerve, Mandibular Nerve Blocks, Premolars
- What is being tested?
- inferior alveolar nerve block with 4% articaine and Mental/Incisive Nerve Block (%4 Articaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 15 Sep 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals classified as ASA 1 or ASA 2.
- Age range of 18 to 65 years.
- No known allergies to articaine or epinephrine.
- Absence of facial paresthesia.
- No use of analgesic medications within 6 hours prior to treatment.
- No use of medications, such as tricyclic antidepressants or beta blockers, that may interfere with anesthesia.
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- No pathological conditions at the planned injection site.
- Periodontal pocket depth of 3 mm or less.
- Mandibular first or second premolars diagnosed with symptomatic irreversible pulpitis.
- Teeth meeting Glickman's gingival health criteria upon periodontal examination.
- Radiographically closed root apex with no detectable pathology.
- Patients must be literate and able to comprehend the use of a pain scale to provide informed consent voluntarily.
Who cannot join
- Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
- Pregnancy.
- Documented allergy to articaine with 1:100,000 epinephrine.
- Evidence of periapical pathology or radiolucency observed in radiographs.
- Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
- Absence of reported lip numbness 10 minutes following IANB or MINB injection. Presence of a large restoration on the affected tooth.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Dentistry Faculty Department of Endodontics Clinic
Adana, 01380
About this study
Official title: Anesthetic Effectiveness of Mental/incisive Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular I. and II. Premolars with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
The goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. This study aims to address gaps in current evidence and clarify whether these anesthesia techniques differ in effectiveness and patient experience during endodontic procedures. The hypotheses include: (i) no difference in pain perception between IANB and MNB, (ii) no difference between first and second premolars with IANB, and (iii) no difference between first and second premolars with MNB.
- Being tested
- inferior alveolar nerve block with 4% articaine, Mental/Incisive Nerve Block (%4 Articaine)
- Keywords
- Inferior alveolar nerve block, local anesthesia, mental nerve block, pain, premolar
- Medical subject headings
- Bicuspid Aortic Valve Disease, Pain
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% articaineOther
A single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Inferior Alveolar Block anesthesia via the mandibular foramen.
Mental/Incisive Nerve Block (%4 Articaine)Other
A single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Mental or Incisive Nerve Block anesthesia via the mental foramen.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveoler Nerve Block | Experimental | Not described Receives: Other: inferior alveolar nerve block with 4% articaine |
| Mental/Incisive Nerve Block | Experimental | Not described Receives: Other: Mental/Incisive Nerve Block (%4 Articaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
The patients were asked to rate the pain experienced during endodontic access cavity preparation and pulp extirpation using a Numerical Rating Scale. The Numerical Rating Scale was printed on A4 paper, scaled to fit horizontally, with values from 0 to 10 displayed along a bar. The Numerical Rating Scale uses a 0 to 10 scale, with increments of one unit. Patients were instructed to mark '0' if they experienced no pain, select a value between "1" and "3" for mild pain, a value between "4" and "6" for moderate pain, and a value between "7" and "10" for severe pain.
Measured: Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start20 Feb 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular NerveStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized clinical study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolga Sulek, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679660
- Sponsor's protocol ID
- 2023/130/86
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Effectiveness of Mental/incisive Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular I. and II. Premolars with Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06679660
- Acronym / sponsor ID
- 2023/130/86
- Keywords
- Inferior alveolar nerve block, local anesthesia, mental nerve block, pain, premolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 7 Nov 2024 (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 goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. This study aims to address gaps in current evidence and clarify whether these anesthesia techniques differ in effectiveness and patient experience during endodontic procedures. The hypotheses include: (i) no difference in pain perception between IANB and MNB, (ii) no difference between first and second premolars with IANB, and (iii) no difference between first and second premolars with MNB.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveoler Nerve Block | Experimental | Other: inferior alveolar nerve block with 4% articaine |
| Mental/Incisive Nerve Block | Experimental | Other: Mental/Incisive Nerve Block (%4 Articaine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals classified as ASA 1 or ASA 2.
- Age range of 18 to 65 years.
- No known allergies to articaine or epinephrine.
- Absence of facial paresthesia.
- No use of analgesic medications within 6 hours prior to treatment.
Key exclusion criteria (6 listed)
- Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
- Pregnancy.
- Documented allergy to articaine with 1:100,000 epinephrine.
- Evidence of periapical pathology or radiolucency observed in radiographs.
- Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
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 single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Inferior Alveolar Block anesthesia via the mandibular foramen. | Other | Inferior Alveoler Nerve Block |
| Mental/Incisive Nerve Block (%4 Articaine)A single ampoule of 4% articaine was administered to a cohort of patients presenting with irreversible pulpitis in the first or second mandibular premolars, designated for Mental or Incisive Nerve Block anesthesia via the mental foramen. | Other | Mental/Incisive Nerve Block |
Primary outcome
Numerical Rating Scale
Time frame: Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.
The patients were asked to rate the pain experienced during endodontic access cavity preparation and pulp extirpation using a Numerical Rating Scale. The Numerical Rating Scale was printed on A4 paper, scaled to fit horizontally, with values from 0 to 10 displayed along a bar. The Numerical Rating Scale uses a 0 to 10 scale, with increments of one unit. Patients were instructed to mark '0' if they experienced no pain, select a value between "1" and "3" for mild pain, a value between "4" and "6" for moderate pain, and a value between "7" and "10" for severe pain.
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 12 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Mental/Incisive Nerve Block (%4 Articaine) in people with Mandibular Nerve and Mandibular Nerve Blocks, run by Cukurova 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 12 inclusion and 6 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 12 Nov 2024. 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?
Numerical Rating Scale (time frame: Following anesthesia administration, a 10-minute waiting period was observed. Patients completed a Numerical Rating Scale immediately upon initiation of the endodontic cavity procedure and again after the start of pulp extirpation.). 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 12 Nov 2024.