Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children

Study Overview
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Brief Summary
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Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. Intervention Description Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Detailed Description
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Methodology Ethical Clearance:The study will be registered at the clinical trials registry of the United States National Institutes of Health (NIH), following which ethical approval will be obtained from the institutional review board of the Riyadh Colleges of Dentistry and Pharmacy Patient Recruitment The sample will comprise of 60 children reporting to the clinics of the Riyadh Colleges of Dentistry and Pharmacy determine to have treatment that involve the use of local anesthesia. Sample Power Calculation Sample power calculation was done using the G Power sample size calculator (Universtat Kiel, Kiel, Germany) . Given the split mouth study design proposed a high effect size of 0.8 was assumed. The minimum number of individuals for an alpha of 0.05 and a power of 0,95 was 19 subjects per group. Given the risk of attrition of subjects in the study, the total sample size recruited will be 30 per group (n=60) The Inclusion Criteria Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. The classification of each patient will be done separately by two experienced pediatric dentists (NG and SCP) and consensus on the classification will be obtained before including the patient in the study. Informed consent will be obtained from the parent of all patients who agree to participate in the study. Exclusion Criteria Patients with a history of hospitalization or surgery, those with chronic illness will be excluded from the study. The study will also exclude patients diagnosed with neurobehavioral disorders such as autism, ADHD or learning disability. Patients with congenital syndromes or intellectual disability will also be excluded from the study. Intervention Description Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Official Title
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Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children - A Split Mouth Randomized Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Device: Buzzy
* Drug: 2%Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No prior experience of dental anesthesia At least one upper tooth on either side requiring anesthesia before restoration Exclusion Criteria: History of mental illness Extensive hospitalization for chronic illness Past history of surgery

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Group<br>Children will be administered buccal infiltration anesthesia using a 21mm needle and 1.8ml of 2%Lidocaine | Drug: 2%Lidocaine<br>* 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage)<br>* Other names: Lignocaine;|
| Experimental: Buzzy<br>Children will be administered buccal infiltration anesthesia using a 21mm needle and 1.8ml of 2%Lidocaine after sensitizing the area with a vibrating device | Device: Buzzy<br>* Two minute application of a hand held vibrating device (Buzzy, MMJ labs, Atlanta GA, USA) before the administration of anesthesia<br>* Other names: Vibrating Device;Drug: 2%Lidocaine<br>* 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage)<br>* Other names: Lignocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of injection ( Wong Baker Face Pain Scale) | Pain felt on injection measured using the Wong Baker Face Pain Scale | 0 min - at the time of injection | 
| Pain of injection ( Wong Baker Face Pain Scale) | Pain felt measured using the Wong Baker Face Pain Scale | 5 min after the injection | 
| Pain of injection ( Wong Baker Face Pain Scale) | Pain felt measured using the Wong Baker Face Pain Scale | 30 min after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior ( Frankl behavior rating scale) | Behavior measured using the Frankl behavior rating scale | 5min before procedure, 5 min after completion of procedure |