Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

NCT06290531 | Completed

• 1 other identifier: CEBD-CU-2023-11-12
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children. The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores. Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.

Conditions

Dental Caries in Children

Keywords

Local Anesthesia; Buzzy; Topical Anesthesia; Pain; precooling

Outcome Measures

Primary Outcomes (1)

• Patient reported pain during needle injection

  Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score

  Immediately post injection

Secondary Outcomes (4)

• Child behaviour during needle injection

  Immediately during injection

• Heart rate

  Immediately post injection

• Oxygen saturation

  Immediately post injection

• Child and parent satisfaction

  Immediately post injection

Study Arms (4)

Buzzy device (cold and vibration)

EXPERIMENTAL

Device: Buzzy device (cold and vibration)

Buzzy device (vibration only)

EXPERIMENTAL

Device: Buzzy device (vibration only)

Precooling

EXPERIMENTAL

Other: precooling

Flavored Benzocaine topical anesthetic gel 20%

ACTIVE COMPARATOR

Other: Flavored Benzocaine topical anesthetic gel 20%

Interventions

Buzzy device (cold and vibration) DEVICE

The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction

Buzzy device (cold and vibration)

Buzzy device (vibration only) DEVICE

The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction

Buzzy device (vibration only)

precooling OTHER

Ice cubes used for applying coolness at the injection area

Precooling

Flavored Benzocaine topical anesthetic gel 20% OTHER

Topical anesthetic gel

Flavored Benzocaine topical anesthetic gel 20%

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children in the mixed dentition stage,
• Age range 6-12 years old,
• Need extraction to a maxillary molar,
• Cooperative and medically free.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatma KI Abdelgawad, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 4, 2024
• Study Start: January 16, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)