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Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia for the Extraction of Primary Mandibular Molars

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05221190
Collaborator
(none)
112
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
22.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Single buccal infiltration
  • Procedure: Inferior alveolar nerve block
 N/A

Detailed Description

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single buccal infiltration of articaine anesthesia

The local anesthetic solution will be administered using single buccal infiltration with articaine anesthesia.

Procedure: Single buccal infiltration
injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.
Other Names:
  • Articaine buccal infiltration

    		•
    Active Comparator: Inferior alveolar nerve block of lidocaine anesthesia

    The anesthetic solution will be administered using inferior alveolar nerve block with lidocaine anesthesia.

    Procedure: Inferior alveolar nerve block
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of intraoperative pain [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 Outcome Measures

    1. intraoperative pain [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 [up to 24 hours]

      stopwatch

    3. duration of the anesthetic effect [up to 24 hours]

      stopwatch

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo university Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: marwa m elchaghaby, phd, marwaaly2003@yahoo.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    marwa aly fouad elchaghaby, principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05221190
    Other Study ID Numbers:
    • Anesthetic techniques
    First Posted:
    Feb 2, 2022
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Feb 2, 2022