Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children

Study Overview
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Brief Summary
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Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.

Official Title
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Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Other: Buccal and direct palatal injection with the aid of Buzzy
* Other: Buccal and indirect palatal injection with the aid of Buzzy
* Other: Buccal and direct palatal injection without Buzzy
* Other: Buccal and indirect palatal injection without Buzzy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are in need of extraction of maxillary posterior teeth. Children free of any systemic disease or special health care needs (ASA I). Children with no learning disabilities. Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale. Patients whose parents will give consent to participate. Exclusion Criteria: Having active sites of pathosis in the area of injection that could affect the anesthetic assessment. Signs of reversible pulpitis. Restorable tooth. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia. Patients with acute oral or facial infection (swelling and/or cellulites )

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct local anesthesia with Buzzy<br> | Other: Buccal and direct palatal injection with the aid of Buzzy<br>* Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection<br>|
| Experimental: Indirect local anesthesia with Buzzy<br> | Other: Buccal and indirect palatal injection with the aid of Buzzy<br>* Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection<br>|
| Active Comparator: Direct local anesthesia<br> | Other: Buccal and direct palatal injection without Buzzy<br>* Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection<br>|
| Active Comparator: Indirect local anesthesia<br> | Other: Buccal and indirect palatal injection without Buzzy<br>* Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scores | Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain. | Baseline and up to 1 hour | 
| Change in child's behavior | Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections. Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental injection, Palatal injection, Indirect palatal injection