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

Not Applicable

Completed

• Conditions: Anesthetics, Local
• Interventions: Device: DentalVibe® Comfort Injection System; Drug: Lidocaine Epinephrine

• Registration Number: NCT03839134
• Lead Sponsor: Riyadh Colleges of Dentistry and Pharmacy

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-10
• Study First Posted: 2019-02-15
• Study Start: 2019-03-20
• Primary Completion: 2019-08-01
• Status Verified: 2019-09
• Study Completion: 2019-09-05
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pain of palatal injection with DentalVibe®	Lidocaine Epinephrine	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.
Pain of block injection without DentalVibe®	Lidocaine Epinephrine	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.
Pain of palatal injection without DentalVibe®	Lidocaine Epinephrine	Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
Pain of block injection with DentalVibe®	Lidocaine Epinephrine	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.
Pain of buccal injection with DentalVibe®	DentalVibe® Comfort Injection System	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.
Pain of palatal injection with DentalVibe®	DentalVibe® Comfort Injection System	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.
Pain of buccal injection without DentalVibe®	Lidocaine Epinephrine	Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
Pain of block injection with DentalVibe®	DentalVibe® Comfort Injection System	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.
Pain of buccal injection with DentalVibe®	Lidocaine Epinephrine	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 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.
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 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.

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia