Clinical trial NCT06679660: Comparative Assessment of Mental/Incisive and Inferior Alveolar Nerve Block Anesthesia in Root Canal Treatment of Mandibular Premolars
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Nerve
Mandibular Nerve Blocks
Premolars
Mental Nerve Block
Keywords: Inferior alveolar nerve block
local anesthesia
mental nerve block
pain
premolar
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized clinical study
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Dentistry Faculty Department of Endodontics Clinic
Study officials:
References: