NCT06333730

Brief Summary

Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth. Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB. Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included. Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded. Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

October 31, 2023

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS

    Pain after anesthesia in both groups will be assessed through Visual Pain analogue scale and greater than 3 will be considered ineffective

    Two months

Study Arms (2)

Inferior Alveolar Nerve Block (IANB)

EXPERIMENTAL

48 patients will be randomly selected in inferior alveolar nerve block group

Procedure: inferior alveolar nerve block

Mental Nerve Block (MNB)

EXPERIMENTAL

48 patients will be randomly selected in mental nerve block group

Procedure: mental nerve block

Interventions

After informed consent, the needle will be inserted into the muco-buccal fold adjacent to the mandibular molars and advanced it towards the mandibular foramen, aiming slightly anteriorly and superiorly. Aspirating to check for blood or resistance, the needle will be repositioned if either was present. Once the needle will be correctly positioned, the dental practitioner will slowly inject 1.8-1.9 mL of the anesthetic solution.

Inferior Alveolar Nerve Block (IANB)

After informed consent, the needle will be inserted into the buccal fold between the lower premolars. Aspirating to check for blood or resistance. Once needle is correctly positioned, 0.6-0.9 ml of the anesthetic solution will be deposited.

Mental Nerve Block (MNB)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with mandibular premolars or lower anterior
  • Experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester
  • Bleeding during access opening

You may not qualify if:

  • Participants with a medical history
  • Allergies or contraindications to the local anesthetic
  • Pregnant or breastfeeding women
  • Patient taking pain-affecting medication
  • Patient experiencing pain in more than one tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peshawar Dental College

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Study Officials

  • Saifa Rashad, BDS

    Peshawar Dental College

    STUDY CHAIR

Central Study Contacts

Iftikhar Akbar, FCPS, CHIPE

CONTACT

Marghalara Noor, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Operative dentistry & Endodontic, Professor, Principal investigator

Study Record Dates

First Submitted

October 31, 2023

First Posted

March 27, 2024

Study Start

April 1, 2024

Primary Completion

May 30, 2024

Study Completion

June 20, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

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