Anxiety, Pain
Conditions
Brief summary
The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer \[is/are\]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.
Interventions
PROCEDUREDental anesthesia injector
Dental anesthesia injector
Sponsors
Shahad Abudawood
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged between 6-12 years old * Medically fit * Requiring dental restorative procedures (Filling).
Exclusion criteria
* Children younger than 6 years * Children older than 12 years * Any significant medical history * Requiring extensive restorative dental work type such as full crown coverage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Baseline and immediate post-procedure | Wong-Baker FACES Pain Rating Scale, is a self-report measure consisting of a series of six facial expressions (FACES) representing increasing levels of pain. Scores range from 0 to 10, with 0 (happy face) indicating "no hurt" and 10 ( a crying face) indicating "hurts worst". Higher scores represent greater pain intensity and therefore a worse outcome. |
| Anxiety using the Modified Dental Anxiety Scale (MDAS) | Baseline and immediate post- procedure | The Modified Dental Anxiety Scale is a self-reported measure of dental anxiety consisting of five items, each scored on a 5-point Likert scale. Total scores range from 5 to 25, with 5 indicating no dental anxiety and 25 indicating extreme dental anxiety. Higher scores represent greater dental anxiety and therefore a worse outcome. |
Countries
Saudi Arabia
Outcome results
None listed