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NCT Number: NCT05221190

Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia

This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.

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Key information

Conditions

Anesthesia

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, Egypt

About this study

Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance .

The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve.

Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children .

However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips .

An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present.
  • Children ranging in age from 5-8 years

Exclusion criteria

.Allergies to local anesthetics.

  • History of significant medical conditions.
  • Children under any medications.
  • Presence of abscess, sinus opening.
  • Uncooperative children without access to or with difficulty accessing dental care.

Treatment and study plan

Single buccal infiltration

Procedure

injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.

Other names: Articaine buccal infiltration

Inferior Alveolar Nerve Block

Procedure

Injection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible.

Other names: Lidocaine nerve block

Primary outcomes

  1. Assessment of intraoperative pain

    Time frame: through treatment completion, an average of 1 hour

    Wong Baker Faces Pain Rating Scale consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears with numerical value from 0 to 5 where where zero indicates no pain and 5 indicate severe pain

Secondary outcomes

  1. intraoperative pain

    Time frame: through treatment completion, an average of 1 hour

    Faces, Legs, Activity, Cry, and Consolability scale with score from 0 to 10 where zero indicates no pain and 10 indicate severe pain

  2. The onset of the anesthetic effect

    Time frame: up to 24 hours

    stopwatch

  3. duration of the anesthetic effect

    Time frame: up to 24 hours

    stopwatch

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Evaluation of the Effectiveness of Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia for the Extraction of Primary Mandibular Molars: A Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Nov 16, 2022

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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