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Dental AnxietyNCT07106138

Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience

A study testing Conventional syringe injection, Star Pen and Comfort-In in people with Dental Anxiety and Pain Management, run by Latakia University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe… Read more about this study

Who is it for?
Ages 6 to 10 years
What is being tested?
Conventional syringe injection, Star Pen and Comfort-In
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteSyria
Study dates
23 Apr 2024to 10 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6-10 years.
  • Physically healthy with no neurological disorders or systemic diseases.
  • Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
  • Not taking any sedatives or analgesics drugs

Who cannot join

  • Uncooperative children who exhibit clear behavioral problems.
  • Children with systemic diseases or disorders that may interfere with local anesthesia.
  • Use of any medications that may affect vital signs or pain response.
  • Presence of infection at the injection site.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Faculty Of Dentistry ,Tishreen University, lattakia, Syria

    Latakia

Other trials in Syria

About this study

Official title: Comparing the Effectiveness of Several Local Anaesthesic Systems and Thier Effect on Pain Anxiety Behaviour and Vital Signs in Children

compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe, computer-controlled local anesthetic delivery system (Star Pen), needle-free injector (Comfort-In), or a vibrotactile device (Vibraject). Pain was assessed using the FLACC and Wong-Baker FACES scales, anxiety with the Venham Picture Test, and behavior with the Houpt scale. Vital signs including pulse and oxygen saturation were recorded during treatment. Additionally, satisfaction levels of both the patients and their parents were evaluated using structured questionnaires and Likert scales. The study seeks to determine which technique provides the most comfortable and effective experience for children undergoing dental procedures.

Read the detailed description

Local anesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children. Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial investigated and compared four local anesthetic systems: traditional syringe, computer-controlled local anesthetic delivery (CCLAD) using the Star Pen, needle-free injection using Comfort-In, and vibrotactile stimulation with Vibraject.

A total of 112 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of the four anesthesia groups. Pain perception was measured using both the FLACC scale and the Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using the Venham Picture Test before and during the procedure. Child behavior was rated using the Houpt Behavioral Scale. Vital signs including pulse rate and oxygen saturation were monitored at baseline and during treatment. In addition, satisfaction levels were assessed for both the pediatric patients and their accompanying parents, using child-friendly satisfaction questionnaires and parent-rated Likert scales.

This study aims to identify the anesthesia delivery method that best minimizes pain and anxiety, optimizes behavior, maintains physiological stability, and maximizes satisfaction, thereby enhancing the quality of care in pediatric dentistry.

Being tested
Conventional syringe injection, Star Pen, Comfort-In, Vibraject
Keywords
Local anesthetic delivery systems, Computer-controlled anesthesia, Needle-free injection, Vibrotactile Devices, Dental anxiety, Pain management
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional syringe injectionDevice

    Manual injection using a conventional dental syringe and needle to deliver local anesthetic.

  • Star PenDevice

    A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.

  • Comfort-InDevice

    A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.

  • VibrajectDevice

    A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception

Study groups in NCT07106138
Study groupRoleWhat they receive
Conventional Syringe GroupActive comparator28 Child received local anesthesia using a traditional dental syringe with standard technique.
Receives: Device: Conventional syringe injection
CCLAD - Star Pen GroupExperimental28 Child received Local anesthesia using the Star Pen computer-controlled delivery system
Receives: Device: Star Pen
Comfort-In - Needle-Free GroupExperimental28 Child received local anesthesia using the Comfort-In needle-free jet injector system.
Receives: Device: Comfort-In
Vibraject - Vibrotactile Device GroupExperimental28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device.
Receives: Device: Vibraject

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain level during dental anesthesia and treatment (behavioral assessment)

    Procedural pain was assessed using the FLACC scale, which evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2, for a total score range of 0-10. Higher scores indicate greater pain.Scores were assigned by trained observers during the procedure.

    Measured: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

  2. Pain level during dental anesthesia and treatment (self-reported)

    Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain.

    Higher scores on either scale indicated greater pain intensity.

    Measured: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

  3. Anxiety level during dental anesthesia and treatment

    Anxiety was measured using the Venham Picture Test (VPT),The test consists of eight pairs of cartoon images, each pair containing one figure showing a relaxed expression and one showing an anxious expression. Children were asked to choose the picture that best reflected how they felt. Scores ranged from 0 to 8, with higher scores indicating greater anxiety.

    Measured: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

Secondary outcomes (5)

  1. Child behavior during dental procedures

    Behavior was assessed using the Houpt Behavior Rating Scale, which evaluates cooperation during dental procedures.The scale is ranging from 1 (poor) to 6 (excellent). Higher scores indicated better cooperation and comfort during treatment.

    Measured: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

  2. Heart rate

    Heart rate(beats per minute) was monitored using a pulse oximeter to evaluate the physiological stress response throughout treatment .Readings were recorded at predefined intervals. Increases in heart rate indicated heightened stress or discomfort during the procedure.

    Measured: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.

  3. Oxygen saturation during dental procedures

    Oxygen saturation (SpO₂, %) was monitored using a pulse oximeter to evaluate physiological stress response throughout treatment.Readings were recorded at predefined intervals. Decreases in SpO₂ indicated heightened stress or discomfort during the procedure.

    Measured: From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.

  4. Patient satisfaction with anesthesia technique

    Patient satisfaction was assessed using a structured questionnaire with two yes/no questions:

    1. Are you satisfied with the experience? (Yes/No)
    2. Would you like to have the same technique in future visits? (Yes/No) Responses were coded as binary outcomes (Yes = 1, No = 0). Higher total scores indicated greater patient satisfaction.

    Measured: Immediately after the procedure

  5. Parental satisfaction with anesthesia technique

    Parents rated their satisfaction using a Likert scale survey covering perceived child comfort and procedural experience. Scores ranged from 1 (very dissatisfied) to 5 (very satisfied). Higher scores reflected greater parental satisfaction with the anesthesia method used.

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start23 Apr 2024
  3. Primary completion29 Nov 2024
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106138
Sponsor's protocol ID
Tishreen U_pedodontic
Status last verified
Aug 2025
First submitted
22 Jul 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional syringe injection, Star Pen and Comfort-In in people with Dental Anxiety and Pain Management, run by Latakia University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain level during dental anesthesia and treatment (behavioral assessment) (time frame: From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07106138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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