The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients
NCT03839134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2019-09-10
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).
Conditions
- Anesthetics, Local
Interventions
- DEVICE
-
DentalVibe® 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.
- DRUG
-
Lidocaine Epinephrine
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
Sponsors & Collaborators
-
Riyadh Colleges of Dentistry and Pharmacy
lead OTHER
Principal Investigators
-
Ra'ed G Salma · Riyadh Elm University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-03-20
- Primary Completion
- 2019-08-01
- Completion
- 2019-09-05
Countries
- Saudi Arabia
Study Locations
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