Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience
NCT ID: NCT07106138
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2024-04-23
2025-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Conventional Syringe Group
28 Child received local anesthesia using a traditional dental syringe with standard technique.
Conventional syringe injection
Manual injection using a conventional dental syringe and needle to deliver local anesthetic.
CCLAD - Star Pen Group
28 Child received Local anesthesia using the Star Pen computer-controlled delivery system
Star Pen
A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.
Comfort-In - Needle-Free Group
28 Child received local anesthesia using the Comfort-In needle-free jet injector system.
Comfort-In
A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.
Vibraject - Vibrotactile Device Group
28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device.
Vibraject
A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception
Interventions
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Conventional syringe injection
Manual injection using a conventional dental syringe and needle to deliver local anesthetic.
Star Pen
A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.
Comfort-In
A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.
Vibraject
A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception
Eligibility Criteria
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Inclusion Criteria
2. Physically healthy with no neurological disorders or systemic diseases.
3. Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
4. Not taking any sedatives or analgesics drugs
Exclusion Criteria
2. Children with systemic diseases or disorders that may interfere with local anesthesia.
3. Use of any medications that may affect vital signs or pain response.
4. Presence of infection at the injection site.
6 Years
10 Years
ALL
No
Sponsors
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Tishreen University
OTHER
Responsible Party
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Principal Investigators
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Abdul Wahab Nourallah, Prof
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Tishreen University
Sara Badr, PHD student
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Tishreen University
Locations
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Faculty Of Dentistry ,Tishreen University, lattakia, Syria
Latakia, , Syria
Countries
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Other Identifiers
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Tishreen U_pedodontic
Identifier Type: -
Identifier Source: org_study_id
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