Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection
Conditions
Keywords
dental pain, behavior management, local anesthesia in children, pediatric dentistry
Brief summary
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children
Detailed description
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels ) Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups : Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure. Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale . Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale. This study aims to determine whether Star pen® system offers a more comfortable and less anxiety - provoking experience for children compared to the conventional method. The result may guide pediatric dentists in selecting the most suitable delivery technique to improve the dental experience and cooperation in pediatric patients.
Interventions
PROCEDUREcomputer controlled automatic injection (Star pen® system)
local anesthesia will be administered using computer controlled automatic injection(Star pen® system ) to provide slow and consistent anesthetic flow, aiming to reduce pain and anxiety during pediatric dental treatment.
PROCEDUREconventional anesthetic syringe
local anesthesia will be administered using a standard manual dental syringe , following conventional injection techniques for pediatric dental patients.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 6-9 years. * Participants are required to undergo dental procedures requiring local infiltration anesthesia. * Only cooperative patients (scoring 3 or 4 on the Frankl Behavior Scale). * No prior dental experiences. * Patients need maxillary infiltration anesthesia. * No prior symptoms of abscess. * Only children with ASA I health status (Free from developmental or systemic disorders). * Parental consent and child assent required for enrollment. \-
Exclusion criteria
* Medical conditions or systemic illnesses. * Psychiatric conditions affecting pain or anxiety evaluation. * Parental refusal or child unwillingness to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Simplified Faces Pain Scale | Immediately after injection procedure |
| Sound, eye, motor scale | Starting From point entry of anesthesia till end of injection procedure |
Secondary
| Measure | Time frame |
|---|---|
| pulse oximeter | From sitting of patient on dental chair till the end of the injection procedure |
| Venham Behavior Rating Scale | Starting From point of entry of anesthesia till end of injection procedure |
Countries
Egypt
Outcome results
None listed