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NCT Number: NCT07771452

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

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.

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erfan specialized dental center

Herat, Herāt, 3002, Afghanistan

About this study

This prospective, single-arm pilot study was conducted to evaluate a combined local anesthetic technique for mandibular molar procedures without the use of a conventional inferior alveolar nerve block (IANB). Patients requiring dental treatment involving mandibular molars were enrolled according to predefined eligibility criteria.

Local anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized technique consisted of three components: supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Initially, 0.2 mL of anesthetic solution was administered supraperiosteally, followed by 0.2 mL subperiosteally with deeper needle penetration. PDL anesthesia was then administered on both the mesial and distal aspects of the involved tooth, using 0.5 mL of anesthetic solution at each site.

Anesthetic effectiveness was clinically assessed before and during the planned dental procedure. If adequate anesthesia was not achieved after the initial administration, the combined anesthetic protocol was repeated once. The need for additional conventional inferior alveolar nerve block anesthesia was recorded. Participants were also followed for 48-72 hours to identify any complications associated with the anesthetic technique.

The study included mandibular molars requiring restorative treatment, root canal treatment, extraction, or immediate implant placement. The study was intended to provide preliminary clinical evidence regarding the feasibility and effectiveness of this combined local anesthetic approach and to inform the design of future controlled clinical trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Complete Procedural Anesthesia After the First Application

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

    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.

  2. Number of Participants With Successful Anesthesia After Initial Administration

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

    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.

  3. Successful anesthesia after initial administration

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

    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.

Sponsors and collaborators

Lead sponsor

Herat University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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