NCT06116994: Camouflage

The Effect of Using Camouflaged Dental Syringe

Status unknown NA Last updated 3 November 2023

What this trial tests

NA trial testing The buccal infiltration anesthesia with a camouflaged dental syringe (Angelus ™) in Anxiety, Dental in 60 participants. Status unknown.

Timeline

30 October 2023

Primary endpoint
30 October 2023

30 December 2023

Quick facts

Lead sponsor	King Abdulaziz University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	30 October 2023
Primary completion	30 October 2023
Estimated completion	30 December 2023
Sites	1 location across Saudi Arabia

Drugs / interventions tested

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

Conditions studied

• Anxiety, Dental — all drugs for Anxiety, Dental →
• Behavior — all drugs for Behavior →

Sponsor

King Abdulaziz University

Who can join

Adults 6 to 10, any sex, with Anxiety, Dental or Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effect of Using a Camouflaged Dental Syringe on Children's Anxiety and Behavioral Pain.
   Bagher SM, Felemban OM, Alsabbagh GA, Aljuaid NA. · · 2023 · cited 8× · PMID 38186474 · DOI 10.7759/cureus.50023