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Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children

NCT03445182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-06-04

No results posted yet for this study

Summary

The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.

The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, where as DV is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - CS or CS+DV.

Conditions

  • Pain Management
  • Local Anaesthesia

Interventions

PROCEDURE

Local anaesthesia with conventional syringe

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. Local anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

DEVICE

Local anaesthesia with conventional syringe + Dentalvibe

Buccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on. Local anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL

Sponsors & Collaborators

  • Plovdiv Medical University

    lead OTHER

Principal Investigators

  • Ani Beltcheva · Medical University - Plovdiv, Bulgaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-06-10
Completion
2019-09-10

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445182 on ClinicalTrials.gov