Anesthetics, Local
Conditions
Brief summary
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).
Interventions
DEVICEDentalVibe® Comfort Injection System
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.
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Sponsors
Riyadh Colleges of Dentistry and Pharmacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of needle penetration of buccal LA injection | 1-2 seconds after mucosal penetration | 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. |
| Pain of anesthesia delivery during buccal LA infiltration | 30 seconds after LA solution delivery | 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. |
| Pain of needle penetration of palatal LA injection | 1-2 seconds after mucosal penetration | 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. |
| Pain of anesthesia delivery during palatal LA infiltration | 30 seconds after LA solution delivery | 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. |
| Pain of needle penetration of IAN block LA injection | 1-2 seconds after mucosal penetration | 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. |
| Pain of anesthesia delivery during IAN block LA injection | 30 seconds after LA solution delivery | 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. |
Countries
Saudi Arabia
Outcome results
None listed