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

NCT03839134 | Completed

• 1 other identifier: FRP/2018/286
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthetics, Local

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (6)

Pain of buccal injection with DentalVibe®

EXPERIMENTAL

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; Drug: Lidocaine Epinephrine

Pain of buccal injection without DentalVibe®

ACTIVE COMPARATOR

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

Pain of palatal injection with DentalVibe®

EXPERIMENTAL

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; Drug: Lidocaine Epinephrine

Pain of palatal injection without DentalVibe®

ACTIVE COMPARATOR

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

Pain of block injection with DentalVibe®

EXPERIMENTAL

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; Drug: Lidocaine Epinephrine

Pain of block injection without DentalVibe®

ACTIVE COMPARATOR

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

Interventions

DentalVibe® Comfort Injection System DEVICE

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.

Also known as: DentalVibe

Pain of block injection with DentalVibe®; Pain of buccal injection with DentalVibe®; Pain of palatal injection with DentalVibe®

Lidocaine Epinephrine DRUG

Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).

Also known as: Xylocaine 2% with Epinephrine

Pain of block injection with DentalVibe®; Pain of block injection without DentalVibe®; Pain of buccal injection with DentalVibe®; Pain of buccal injection without DentalVibe®; Pain of palatal injection with DentalVibe®; Pain of palatal injection without DentalVibe®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status class I
• Planned for multiple dental treatments in the maxilla and mandible bilaterally

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Elm University

Riyadh, 12734, Saudi Arabia

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ra'ed G Salma

  Riyadh Elm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: March 20, 2019
• Primary Completion: August 1, 2019
• Study Completion: September 5, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)