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

NCT ID: NCT06679660

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-09-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Inferior Alveoler Nerve Block

Group Type: EXPERIMENTAL

inferior alveolar nerve block with 4% articaine

Intervention Type: 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.

Mental/Incisive Nerve Block

Group Type: EXPERIMENTAL

Mental/Incisive Nerve Block (%4 Articaine)

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Tolga Sulek

Specialist of Endodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cukurova University Dentistry Faculty Department of Endodontics Clinic

Adana, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/130/86

Identifier Type: -

Identifier Source: org_study_id