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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Syringe Group | Active Comparator | 28 Child received local anesthesia using a traditional dental syringe with standard technique. |
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| CCLAD - Star Pen Group | Experimental | 28 Child received Local anesthesia using the Star Pen computer-controlled delivery system |
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| Comfort-In - Needle-Free Group | Experimental | 28 Child received local anesthesia using the Comfort-In needle-free jet injector system. |
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| Vibraject - Vibrotactile Device Group | Experimental | 28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional syringe injection | Device | Manual injection using a conventional dental syringe and needle to deliver local anesthetic. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes. |
| 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. | From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes. |
| 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. | From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdul Wahab Nourallah, Prof | Faculty of Dentistry, Tishreen University | Principal Investigator |
| Sara Badr, PHD student | Faculty of Dentistry, Tishreen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Of Dentistry ,Tishreen University, lattakia, Syria | Latakia | Syria |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Star Pen | Device | A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort. |
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| Comfort-In | Device | A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort. |
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| Vibraject | Device | A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception |
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| 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. | From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes. |
| 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. | From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes. |
| Patient satisfaction with anesthesia technique | Patient satisfaction was assessed using a structured questionnaire with two yes/no questions:
| Immediately after the procedure |
| 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. | Immediately after the procedure |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |