Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

Dental Caries in Children Clinical Trial

Official title:

Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290531
• Other study ID #: CEBD-CU-2023-11-12
• Status: Completed
• Phase: N/A
• Start date: January 16, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children in the mixed dentition stage,

• Age range 6-12 years old,

• Need extraction to a maxillary molar,

• Cooperative and medically free.

Exclusion Criteria:

• Exclusion will be performed if the parent refused the participation of their children in the research.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Device:
• Buzzy device (cold and vibration)
The device produces cold and vibration to act on the gate control theory and provide painless injection by nerve distraction
• Buzzy device (vibration only)
The device produces vibration to act on the gate control theory and provide painless injection by nerve distraction

Other:
• precooling
Ice cubes used for applying coolness at the injection area
• Flavored Benzocaine topical anesthetic gel 20%
Topical anesthetic gel

Locations

Country	Name	City	State
Egypt	Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Child behaviour during needle injection	Child behaviour during needle injection was recorded using Sound-eye-motor scale (0-9) with 9 is the worst score	Immediately during injection
Secondary	Heart rate	Heart rate was recorded using pulse oximetry (beats/minute)	Immediately post injection
Secondary	Oxygen saturation	Oxygen saturation was recorded using pulse oximetry	Immediately post injection
Secondary	Child and parent satisfaction	By asking questions to both child and their parent on a likert scale for children ( positive, neutral and negative) for parents ( strongly agree, agree, no opinion, disagree and strongly disagree)	Immediately post injection