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

NCT03445182 | Completed

• 1 other identifier: PlovdivMU1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain control; paediatric dental patients; local anaesthesia; dentalvibe

Outcome Measures

Primary Outcomes (1)

• Pain felt during injection using visual analogue scale

  Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.

  Immediately after local anaesthetic delivery

Secondary Outcomes (5)

• Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale

  During local anaesthesia procedure

• Self-reported anxiety during injection evaluated on FIS

  Immediately after local anaesthetic delivery

• Heart rate dynamics of the patient

  Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.

• Assessment of self-reported dental fear on CFSS-DS questionnaire

  Prior to each visit

• Patient preference to local anaesthesia method

  One week after second procedure

Study Arms (2)

Control group

ACTIVE COMPARATOR

Local anaesthesia with conventional syringe

Procedure: Local anaesthesia with conventional syringe

DentalVibe group

ACTIVE COMPARATOR

Local anaesthesia with conventional syringe + DentalVibe

Device: Local anaesthesia with conventional syringe + Dentalvibe

Interventions

Local anaesthesia with conventional syringe PROCEDURE

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

Control group

Local anaesthesia with conventional syringe + Dentalvibe DEVICE

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

DentalVibe group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events.
• Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
• Patients with allergy to local anesthetics of the amide group.
• Children, who are first time ever dental patients.
• Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
• Children, requiring local anaesthesia infiltration for extraction of two primary upper jaw molars bilaterally.
• Indications for extraction of primary molars: over-retention - in case of delayed physiological change and tendency of eruption of the permanent tooth; orthodontic reasons - tooth removed to prevent or correct malocclusion; advanced root resorption and imminent physiological tooth replacement; teeth with a severely damaged clinical crown (from trauma or caries and its complications); teeth with failed pulpotomy, acute or chronic diffuse periodontitis, endangering the germ of the permanent tooth.
• Obtained informed consent from parents or gave-givers to participate in the study.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

Faculty of Dental Medicine, Medical University - Plovdiv

Plovdiv, 4000, Bulgaria

Location

Related Publications (1)

• Veneva E, Cholakova R, Raycheva R, Belcheva A. Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Jul 2;9(7):e029460. doi: 10.1136/bmjopen-2019-029460.

  PMID: 31270121 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ani Beltcheva

  Medical University - Plovdiv, Bulgaria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Intervention Model: Split-mouth assignment

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: April 1, 2018
• Primary Completion: June 10, 2019
• Study Completion: September 10, 2019
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)