Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children

Study Overview
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Brief Summary
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The study assesses the effect of a new vibration system on pain reduction during the injection of local anesthesia. Children undergoing dental treatment are allocated to two groups; one receiving the Buzz, a vibration system and another group receiving nothing. Pain during injection of local anesthetic is assessed using a validated tool in addition to assessment of child cooperation during treatment.

Detailed Description
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Eligibility of children for inclusion into the study will be assessed followed by random sequence generation and randomization into one of the two study group and allocation concealment. Topical anaesthesia will be administered to the two groups followed by implementation of the vibration system in the test group. . Behavior and pain will assessed at the time of injection.

Official Title
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Effect of a Vibration System on Pain Reduction During Injection of Local Dental Anaesthesia in Children: a Randomized Controlled Clinical Trial

Conditions
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Local Anaesthetic, Dental Anxiety

Intervention / Treatment
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* Device: Adminstration Technique using Buzzy external distractor
* Drug: 2% Lidocaine with 1:50,000 epinephrine
* Drug: Topical Anesthetic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 5-12 years of age. Positive or definitely positive behavior on Frankl scale.6 Children receiving treatment on the dental chair. Free from allergies to topical anesthetic used in the study. Parental consent for child participation in the study. Exclusion Criteria: Those in need of treatment under general anesthesia will be excluded from the study. Children with allergies from topical anesthesia

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buzzy<br>Buzzy was used during Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel. | Device: Adminstration Technique using Buzzy external distractor<br>* External application of Buzzy distractor during administration of dental anesthetic<br>Drug: 2% Lidocaine with 1:50,000 epinephrine<br>* Local Dental anesthetic infiltration<br>Drug: Topical Anesthetic<br>* 20% Benzocaine gel was applied on the area of infiltration<br>|
| Active Comparator: Control<br>Maxillary anesthetic infiltration injection with 2%lidocaine with 1:50,000 epinephrine after topical application with 20% Benzocaine topical gel only. | Drug: 2% Lidocaine with 1:50,000 epinephrine<br>* Local Dental anesthetic infiltration<br>Drug: Topical Anesthetic<br>* 20% Benzocaine gel was applied on the area of infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported pain intensity: Visual analogue scale (VAS) of pain intensity | Self reported pain intensity before the injection and directly after the injection. Each child scored pain intensity twice, one before the injection and one directly after the injection (0=no pain; 10=Very painful). | Procedure (immediately after the administration of Dental anesthesia) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents Perception for the child tolerance of pain; Observational Pain rating scale | The parents were asked about the reaction and attitude of the child during the dental anesthesia administration. Parents rated the child ability to tolerate pain with (0=Didn't Tolerate and 10= Tolerated with a smile) | Procedure (immediately after the administration of Dental anesthesia.) | 
| External observation for Facial and Physical expression. Using Sounds, Eyes, and Motor (SEM) scale (RANGE 0-9). | Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. SEM (0=Comfortable, with no sound, no eye signs of discomfort and Hands are relaxed, no apparent body tenseness, 9= Painful, with verbal complain, crying tears and moving the hands to make aggressive physical contact and pulling the head away. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort. | Procedure (immediately during and after the administration of Dental anesthesia.) | 
| Faces Legs Activity Cry Consolability (FLACC) Scale (RANGE 0-10) | Video was recorded for each child before, during and after the administration of local anesthesia. Each video was assessed by an external calibrated evaluator to score each child response. FLACC (0=The child did not express any facial discomfort with normal legs position no abnormal activity, not crying and relaxed. The highest score 10= Child experienced discomfort, moving his legs jerking crying and difficult to console. The lowest record mean the child was comfortable and the higher the score mean the child experienced discomfort. | Procedure (immediately during and after the administration of Dental anesthesia.) |