Effectiveness of camouflaged syringe in reducing dental anxiety and pain during maxillary local anesthesia in children
| ISRCTN | ISRCTN51025476 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51025476 |
- Submission date
- 24/07/2025
- Registration date
- 24/07/2025
- Last edited
- 24/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Camouflaging is the act of concealing or disguising an object to make it appear less noticeable. It has been proposed as an effective strategy to reduce the visual and psychological threat posed by dental syringes, particularly in children. A syringe with a friendly, non-threatening appearance may help alleviate anxiety and serve as a distraction during injection. However, there remains a limited number of studies investigating the effect of using camouflaged dental syringes, specifically those covered with brightly coloured, animal-shaped sleeves such as crocodiles, on dental fear and anxiety, and how this relates to perceived pain in children. Therefore, the present study aimed to evaluate the effectiveness of a camouflaged dental syringe in reducing dental pain and anxiety during maxillary infiltration anaesthesia in children aged 6–9 years, compared to a conventional syringe.
Who can participate?
Eligible participants were healthy children aged 6 to 9 years requiring dental treatment involving maxillary infiltration local anesthesia. Included participants had no previous dental experience, had not received any sedative or analgesic medication within three hours before the appointment, and demonstrated positive behavior according to the Frankl Behavior Rating Scale.
What does the study involve?
Participants were randomly divided into two groups:
Group 1 (Control Group): Received local anesthesia using the conventional syringe along with the Tell-Show-Do technique (n = 35).
Group 2 (Experimental Group): Received local anesthesia using a camouflaged syringe along with the Tell-Show-Do technique (n = 35).
What are the possible benefits and risks of participating?
Possible benefits are: Performing non-urgent dental treatment in the maxillary arch, such as pulpotomy, serial extraction, and pulpectomy.
Possible risk is: Injection will be painful if the device is not effective.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
December 2023 and May 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mawia Karkoutly, mawia95.karkoutly@damascusuniversity.edu.sy, mawiamaherkarkoutly@hotmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh
Damascus
-
Syria
 ORCID ID |
0000-0003-0227-1560 |
|---|---|
| Phone | +963 992647528 |
| mawiamaherkarkoutly@hotmail.com |
Study information
| Study design | Randomized double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effectiveness of camouflaged syringe in reducing dental anxiety and pain during maxillary local anesthesia in children aged 6–9 years: a randomized controlled clinical trial |
| Study objectives | The study aimed to evaluate the effectiveness of a camouflaged dental syringe in reducing dental pain and anxiety during maxillary infiltration anaesthesia in children aged 6–9 years, compared to a conventional syringe |
| Ethics approval(s) |
Approved 27/03/2023, The Biomedical Research Ethics Committee (Mazzeh, Damascus, -, Syria; +963 992647528; info@damascusuniversity.edu.sy), ref: 2793/2023 |
| Health condition(s) or problem(s) studied | Dental pain and anxiety |
| Intervention | The sample was collected from children who were referred to the Department of Paediatric Dentistry at the Faculty of Dentistry, Damascus University. Participation in the study was openly voluntary, and informed consent was obtained. Before initiating the procedure, each child was asked to express their level of dental anxiety upon sitting in the dental chair by selecting a facial expression that best represented their emotional state, using the FIS. To record physiological parameters, a pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany) was placed on the index finger of the left hand. The device was introduced to the child in a child-friendly manner and described as a happiness meter to enhance acceptance and cooperation. Behavioral management was carried out using the Tell-Show-Do technique to familiarize the child with the components of either the conventional or camouflaged dental syringe, depending on the assigned group. The explanation was delivered using age-appropriate and imaginative language. The conventional syringe (Dental carpule syringe, Dental Laboratorio, china) was described as a magic juice cup in the control group. The camouflaged crocodile-shaped syringe (CROCODILE CASE FOR CARPULE (3u.), Angelus®, Londrina, Brazil) was introduced as a brave knight carrying magic juice in the experimental group. Following this behavioral intervention, the pulse rate was measured again, and anxiety was reassessed using the same FIS. The injection site was then dried, and 20% benzocaine topical anesthetic (Iolite, Dharma Research Inc., Florida, United States) was applied with a cotton applicator for one minute. Subsequently, lidocaine 2% with 1:80,000 epinephrine (2% Lidocaine HCL Injection, Huons Co., Ltd, Seongnam, Korea) was administered via infiltration in the maxillary arch. One minute after the administration of local anesthesia, a third pulse rate measurement was recorded. Postoperative pain was assessed using the FLACC scale, based on video recordings of the entire procedure. The assessments were conducted by two independent, blinded evaluators who reviewed the recordings. Cohen’s Kappa coefficient values of intra-examiner and inter-examiner reliability were > 0.8. Randomisation: Participants were randomly allocated to the study groups using the website www.randomizer.org. Each participant was assigned a unique random number. Randomization was then performed using block randomization via www.randomization.com, allocating participants equally into two randomly permuted groups of 35 children each, with a 1:1 allocation ratio. To prevent allocation bias, the randomization sequence was generated prior to the trial by a third person (a researcher not involved in the study). The investigator conducting the procedures met the participants for the first time in the treatment room after registration and group assignment. This was a double-blind study: both participants and the data analyst were unaware of the group allocations. The children were not informed about their group assignment or the specific aim of the study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | The camouflaged crocodile-shaped syringe (CROCODILE CASE FOR CARPULE (3u.), Angelus®, Londrina, Brazil) |
| Primary outcome measure | 1. Dental anxiety is measured using the Facial Image Scale (FIS) at baseline (before any intervention) and after behavioral management using the Tell-Show-Do technique and introduction to either the camouflaged or conventional syringe, but before administration of topical anesthesia 2. Pulse rate is measured using a finger pulse oximeter at baseline (while seated in the dental chair), after behavioral management and syringe introduction, and one minute after completion of the local anesthetic injection 3. Pain perception is measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during the administration of local anesthesia |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/02/2023 |
| Completion date | 18/05/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Healthy children aged 6 to 9 years requiring dental treatment involving maxillary infiltration local anesthesia 2. Children with no previous dental experience 3. Children who had not received any sedative or analgesic medication within three hours before the appointment 4. Children who demonstrated positive behavior according to the Frankl Behavior Rating Scale |
| Key exclusion criteria | 1. Children unable to communicate effectively 2. Children with physical or cognitive disabilities 3. Uncooperative children exhibiting disruptive behavior 4. Children with acute pulpitis or severe dental abscess 5. Children whose legal guardians refused to provide consent |
| Date of first enrolment | 02/12/2023 |
| Date of final enrolment | 02/05/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
Government
Mazzeh
Damascus
-
Syria
| Phone | +963 992647528 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from mawia95.karkoutly@damascusuniversity.edu.sy, mawiamaherkarkoutly@hotmail.com The type of data that will be shared: Not currently known Timing for availability: Upon a reasonable request Whether consent from participants was required and obtained: Informed consent was obtained |
Editorial Notes
24/07/2025: Trial's existence confirmed by Damascus University.
