Local Anesthesia With Needle-free Injection System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).

Official Title
-----------------
Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth

Conditions
-----------------
Pediatric Anesthesia, Local Anesthesia

Intervention / Treatment
-----------------
* Device: Comfort-in injection system
* Other: conventional injection with dental needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In need of treatment of right and left molar teeth of mandible, Does not have any systemic disorder, High level of communication that can provide logical answers to the questions we ask With parental consent, Volunteers who want to participate in the research 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic Exclusion Criteria: No need for treatment of right and left molar teeth of mandible, Has a systemic condition Low level of communication that cannot provide reasonable answers to the questions we ask Without parental consent Do not want to participate voluntarily in the research Do not attend a check-in Patients not in the 6-12 age group

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>local anesthesia applyed with Comfort in system | Device: Comfort-in injection system<br>* local anesthesia during dental treatment<br>|
| Active Comparator: conventional injection<br>local anesthesia applyed with conventional syringe | Other: conventional injection with dental needle<br>* for local anesthesia during dental treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker Faces Pain Rating Scale (PRS) | The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, no hurt) to 5 (crying/screaming face, hurts worst). | 1 year | 
| Face, Legg, Cry, Consolability Scale (FLACC) | The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
needle-free injection, pain