Comparative Assessment of Mental/Incisive and Inferior Alveolar Nerve Block Anesthesia in Root Canal Treatment of Mandibular Premolars

NCT06679660 | Completed DMC

• 1 other identifier: 2023/130/86
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Nerve; Mandibular Nerve Blocks; Premolars; Mental Nerve Block

Keywords

Inferior alveolar nerve block; local anesthesia; mental nerve block; pain; premolar

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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)

Interventions

inferior alveolar nerve block with 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 Inferior Alveolar Block anesthesia via the mandibular foramen.

Inferior Alveoler Nerve Block

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.

Mental/Incisive Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Dentistry Faculty Department of Endodontics Clinic

Adana, 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Pain

Interventions

Carticaine

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Endodontics

Model Details: Single blinded randomized clinical study

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: February 20, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1)