Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia

NCT05221190 | Completed DMC

• 1 other identifier: Anesthetic techniques
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Assessment of intraoperative pain

  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

  through treatment completion, an average of 1 hour

Secondary Outcomes (3)

• intraoperative pain

  through treatment completion, an average of 1 hour

• The onset of the anesthetic effect

  up to 24 hours

• duration of the anesthetic effect

  up to 24 hours

Study Arms (2)

Single buccal infiltration of articaine anesthesia

EXPERIMENTAL

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

Procedure: Single buccal infiltration

Inferior alveolar nerve block of lidocaine anesthesia

ACTIVE COMPARATOR

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

Procedure: Inferior alveolar nerve block

Interventions

Single buccal infiltration PROCEDURE

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

Also known as: Articaine buccal infiltration

Single buccal infiltration of articaine anesthesia

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.

Also known as: Lidocaine nerve block

Inferior alveolar nerve block of lidocaine anesthesia

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Study Officials

• marwa m elchaghaby, phd

  marwaaly2003@yahoo.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 2, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 3, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

EG (1)