The Effect of Using Camouflaged Dental Syringe

NCT06116994 | Unknown

• 1 other identifier: 053-02-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Seeing the dental syringe can be terrifying, especially for young children. Hiding the dental syringe during local anesthesia (LA) administration can sometimes be challenging for the pediatric dentist. Therefore, this randomized clinical trial aims to assess the effect of a camouflaged dental syringe on children's anxiety and behavioral pain in comparison to the traditional dental syringe during local anesthesia administration in pediatric patients. It will include cooperative and healthy 6-10-year-old children scheduled for non-urgent dental treatment that requires buccal infiltration anesthesia (BIA) in the maxillary arch. The subjects will be randomized into either the test or the control groups. In the test group, subjects will receive BIA using the camouflaged dental syringe. Subjects in the control group will receive the BIA using the traditional dental syringe. A single-trained dentist will administer all the anesthesia. Heart rate (HR) will be monitored at three different time points (before, during, and after) the BIA administration. Subjects' anxiety and behavioral pain will be measured through Venham's Anxiety Rating Scale (VARS) and the Face, Leg, Activity, Cry, and Consolability (FLACC) scale, respectively, by two trained and calibrated investigators.

Conditions

Anxiety, Dental; Behavior

Keywords

Alligator syringe sleeve; anxiety; buccal infiltration; camouflaged syringe; local anesthesia; pediatric dentistry

Outcome Measures

Primary Outcomes (3)

• Anxiety

  Heart rate (HR)

  at three different time points. As a baseline before Local anesthesia administration, the second will be during the needle insertion, and the third point will be one minute after Local anesthesia administration is completed by using a pulse oximeter

• Anxiety

  Venham's Anxiety Rating Scale (VARS)

  during the administration of the local anesthesia, the subjects will be recorded using a high-resolution camera. Later, two trained and calibrated investigators will watch the videos and evaluate the anxiety level of the subjects

• Behavioral pain

  Face, Leg, Activity, Cry, and Consolability Scale (FLACC)

  during the administration of the local anesthesia, the subjects will be recorded using a high-resolution camera. Later, two trained and calibrated investigators will watch the videos and evaluate the anxiety level of the subjects

Study Arms (2)

control group

ACTIVE COMPARATOR

In the control group, subjects will receive the buccal infiltration anesthesia using the traditional dental syringe.

Other: The buccal infiltration anesthesia with a conventional dental syringe

Test group

EXPERIMENTAL

Subjects in the test group will receive the buccal infiltration anesthesia with the camouflaged dental syringe.

Other: The buccal infiltration anesthesia with a camouflaged dental syringe (Angelus ™)

Interventions

The buccal infiltration anesthesia with a camouflaged dental syringe (Angelus ™) OTHER

In the test group, subjects will receive buccal infiltration anesthesia with the a camouflaged dental syringe. The used camouflaged dental syringe (Angelus ™) will consist of an alligator-shaped syringe sleeve that covers the dental syringe and makes it more friendly without affecting its function. The alligator-shaped syringe sleeve has three main components, which are the mouth, trunk, and rear feet. The mouth of the alligator sleeve covers the local anesthesia needle, the trunk covers the syringe barrel of the traditional dental syringe, and the rear feet hold the finger grip.

Test group

The buccal infiltration anesthesia with a conventional dental syringe OTHER

In the control group, subjects will receive buccal infiltration anesthesia with the conventional dental syringe.

control group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy
• Cooperative
• year-old children
• With no known allergy and/or sensitivity to local anesthesia and who are scheduled for non-urgent dental treatment that requires buccal infiltration anesthesia of at least one maxillary molar

You may not qualify if:

• Children who were reported to be uncooperative during their previous dental visit
• Children who did not receive any previous dental treatment at KAUFD and, therefore, have no dental record will be excluded.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King AbdulAziz University

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Sara Bagher, MDS

CONTACT

00966547433525; sbagher@kau.edu.sa

Osama Felemban

CONTACT

ofelemban@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Impossibility to blind the participant and operator to the intervention. The statistician was blinded to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Case Control

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 3, 2023
• Study Start: October 30, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)