The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients

Study Overview
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Brief Summary
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The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).

Official Title
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The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.

Conditions
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Anesthetics, Local

Intervention / Treatment
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* Device: DentalVibe® Comfort Injection System
* Drug: Lidocaine Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status class I Planned for multiple dental treatments in the maxilla and mandible bilaterally Exclusion Criteria: Patients <18 years old Pregnant ladies Smokers and alcoholics Patients on medications Drug abusers Never received dental treatment under local anesthesia before Patients with an acute infection with or without fever Patients with preoperative pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain of buccal injection with DentalVibe®<br>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. | Device: DentalVibe® Comfort Injection System<br>* Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.<br>* Other names: DentalVibe;Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|
| Active Comparator: Pain of buccal injection without DentalVibe®<br>Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. | Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|
| Experimental: Pain of palatal injection with DentalVibe®<br>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. | Device: DentalVibe® Comfort Injection System<br>* Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.<br>* Other names: DentalVibe;Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|
| Active Comparator: Pain of palatal injection without DentalVibe®<br>Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. | Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|
| Experimental: Pain of block injection with DentalVibe®<br>DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection. | Device: DentalVibe® Comfort Injection System<br>* Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.<br>* Other names: DentalVibe;Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|
| Active Comparator: Pain of block injection without DentalVibe®<br>Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. | Drug: Lidocaine Epinephrine<br>* Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).<br>* Other names: Xylocaine 2% with Epinephrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of needle penetration of buccal LA injection | The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 1-2 seconds after mucosal penetration | 
| Pain of anesthesia delivery during buccal LA infiltration | The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 30 seconds after LA solution delivery | 
| Pain of needle penetration of palatal LA injection | The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 1-2 seconds after mucosal penetration | 
| Pain of anesthesia delivery during palatal LA infiltration | The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 30 seconds after LA solution delivery | 
| Pain of needle penetration of IAN block LA injection | The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 1-2 seconds after mucosal penetration | 
| Pain of anesthesia delivery during IAN block LA injection | The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system. | 30 seconds after LA solution delivery |