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Completed

NCT Number: NCT03839134

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

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).

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Key information

Conditions

Anesthetics, Local

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riyadh Elm University

Riyadh, 12734, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: DentalVibe

Lidocaine Epinephrine

Drug

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

Other names: Xylocaine 2% with Epinephrine

Primary outcomes

  1. Pain of needle penetration of buccal LA injection

    Time frame: 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.

  2. Pain of anesthesia delivery during buccal LA infiltration

    Time frame: 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.

  3. Pain of needle penetration of palatal LA injection

    Time frame: 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.

  4. Pain of anesthesia delivery during palatal LA infiltration

    Time frame: 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.

  5. Pain of needle penetration of IAN block LA injection

    Time frame: 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.

  6. Pain of anesthesia delivery during IAN block LA injection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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