A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.

Study Overview
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Brief Summary
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The aim of this study is to determine the efficacy of sweet in compare to virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients. The clinical trial is a randomized split-mouth assignment. Included patients are 5 - 12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas sweet is allocated to first local anesthesia procedure and VR is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS+sweet or CS+VR.

Detailed Description
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Achieving local anesthesia in children is one of the critical aspects of pain management and they effect the quality of treatment as well as behavior of child. A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient. While sweet-tasting reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a pre absorptive mechanism related to the sweet taste. The aim of this study is to determine the efficacy of sweet-testing compare to a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients. The device used in this study is Harga Miniso Vr Glass 3d terbaru, compatible with a mobile phone. The sweet used is xylitol tablet The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 5-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where is the sweet-test applied with first local anesthesia procedure and the virtual reality distraction is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - sweet test infiltration or virtual reality device-assisted injection.

Official Title
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A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia. A Clinical Experimental Study

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride
* Device: Virtual reality device (Harga Miniso Vr Glass 3d terbaru)
* Dietary Supplement: Xylitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, identified as positive or definitely positive through Frankl behavioral rating scale. Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally. Children without previous experience with local anesthesia for dental treatment. Obtained informed consent from parents or gave-givers to participate in the study. Exclusion Criteria: Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion. Vision requiring correction with eyeglasses. Recent injury to the eyes or face that prevents comfortable use of VR hardware or software. Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment. Patients with allergy to local anesthetics, xylitol. Children, who are first time ever dental patients.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized Intervention Model: Split-mouth assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sweet test group<br>Local anesthesia with conventional syringe Procedure: Local anesthesia with conventional syringe + xylitol sublingual tablet Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. | Drug: Lidocaine Hydrochloride<br>* 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle<br>* Other names: lignocaine;Dietary Supplement: Xylitol<br>* Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue<br>* Other names: Xylitol candy;|
| Active Comparator: Virtual reality group<br>Local anesthesia with conventional syringe + VR device Device: Local anesthesia with conventional syringe + VR device Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. | Drug: Lidocaine Hydrochloride<br>* 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle<br>* Other names: lignocaine;Device: Virtual reality device (Harga Miniso Vr Glass 3d terbaru)<br>* Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized<br>* Other names: VR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain felt during injection using visual analogue scale | Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it. | Immediately after local anesthetic delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale | Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain | During local anesthesia procedure | 
| Self-reported anxiety during injection evaluated on FIS | The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1). | Immediately after local anesthetic delivery | 
| Heart rate dynamics of the patient | Patient's left index finger is connected to a portable recording pulse oximeter for children. | Baseline (Start: in the waiting room), at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment. | 
| Assessment of self-reported dental fear on CFSS-DS questionnaire | After each procedure | At least 5 minutes before local anesthesia |