A Combined 2% Lidocaine Anesthetic Technique for Mandibular Molar Procedures Without Inferior Alveolar Nerve Block

NCT07771452 | Completed

• 1 other identifier: ESDC-LA-2025-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-arm pilot study evaluated the clinical effectiveness of a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for dental procedures involving mandibular molars. The technique combined supraperiosteal, subperiosteal, and periodontal ligament injections and was designed to provide adequate local anesthesia without the use of a conventional inferior alveolar nerve block. Participants requiring restorative, endodontic, extraction, or immediate implant procedures involving mandibular molars received the standardized anesthetic protocol. The primary outcome was successful completion of the planned dental procedure without pain requiring additional conventional nerve block anesthesia. The need for repeat administration and the occurrence of complications were also assessed.

Conditions

Procedural Pain

Keywords

Local Anesthesia; Lidocaine; Mandibular molars; Inferior alveolar nerve block; Periodontal ligament injection; supraperiostal injection; Subperiostal injection

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Complete Procedural Anesthesia After the First Application

  Complete procedural anesthesia was defined as adequate procedure-specific pulpal or periodontal anesthesia permitting completion of the planned dental procedure without pain requiring interruption, repetition of the anesthetic protocol, or rescue anesthesia. Anesthetic adequacy was assessed using thermal testing and cautious test cavity preparation for vital teeth, and periodontal probing and initial tooth manipulation for teeth scheduled for extraction.

  From 2 minutes after completion of the initial anesthetic protocol through completion of the planned dental procedure during the same treatment visit.

• Number of Participants With Successful Anesthesia After Initial Administration

  Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.

  During the planned dental procedure, immediately following administration of local anesthesia

• Successful anesthesia after initial administration

  Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.

  During the planned dental procedure, immediately following administration of local anesthesia.

Study Arms (1)

Combined local anesthetic technique

EXPERIMENTAL

Participants received a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for mandibular molar procedures. The protocol consisted of supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Anesthetic effectiveness was assessed clinically during the planned dental procedure. If complete anesthesia was not achieved after the initial administration, the same anesthetic protocol was repeated once. No conventional inferior alveolar nerve block was used.

Drug: Lidocaine 2% with 1:100 000 epinephrine

Interventions

Lidocaine 2% with 1:100 000 epinephrine DRUG

Local anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized protocol consisted of 0.2 mL supraperiosteal injection, followed by 0.2 mL subperiosteal injection with deeper needle penetration, and periodontal ligament (PDL) injections of 0.5 mL on the mesial and 0.5 mL on the distal aspect of the mandibular molar. Anesthetic effectiveness was reassessed after 2 minutes. If complete anesthesia was not achieved, the same protocol was repeated once. No inferior alveolar nerve block was administered.

Combined local anesthetic technique

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 16-60 years.
• Patients requiring dental treatment involving mandibular molars.
• Patients requiring local anesthesia for the planned dental procedure.
• Patients able and willing to provide informed consent.
• For participants younger than 18 years, informed consent was obtained from a - parent or legal guardian.

You may not qualify if:

• Known allergy or hypersensitivity to lidocaine or epinephrine.
• Medical conditions contraindicating the use of lidocaine with epinephrine.
• Presence of acute infection or significant swelling at the injection site.
• Patients unable to cooperate with the dental procedure or assessment of anesthetic effectiveness.
• Patients who declined to participate or provide informed consent.

Sponsors & Collaborators

• Herat University: lead

Study Sites (1)

Erfan specialized dental center

Herat, Herāt, 3002, Afghanistan

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ozair Erfan, Master of Sience

  Stomatology Faculty, Herat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Stomatology Faculty, Herat University

Model Details: This is a prospective, single-arm pilot study in which all participants received the same combined local anesthetic technique for mandibular molar dental procedures. No control or comparator arm was included.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: March 2, 2025
• Primary Completion: April 28, 2025
• Study Completion: May 1, 2025
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AF (1)