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

P

Plovdiv Medical University

Status

Completed

Conditions

Pain Management
Local Anaesthesia

Treatments

Procedure: Local anaesthesia with conventional syringe
Device: Local anaesthesia with conventional syringe + Dentalvibe

Study type

Interventional

Funder types

Other

Identifiers

NCT03445182
PlovdivMU1

Details and patient eligibility

About

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.

Full description

Achieving local anaesthesia in children is one of the critical aspects of pain management. In recent years, several innovative dental appliances have been developed on the concept to reduce the pain of needle injection by applying pressure, vibration, microoscillations or a combination of them. Тhe 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 healthy positive children 8-12 years old requiring local anesthetic infiltration for extraction of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement of dental fear prior to each. Local anaethetic is delivered through buccal infiltration with conventional syringe, where as DentalVibe Comfort System Injection is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - traditional infiltration or DentalVibe-assisted injection.

Enrollment

41 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion criteria:

  • 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.

Inclusion criteria:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

41 participants in 2 patient groups

Control group
Active Comparator group
Description:
Local anaesthesia with conventional syringe
Treatment:
Procedure: Local anaesthesia with conventional syringe
DentalVibe group
Active Comparator group
Description:
Local anaesthesia with conventional syringe + DentalVibe
Treatment:
Device: Local anaesthesia with conventional syringe + Dentalvibe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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