Clinical trial NCT03445182: Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
Official title: Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Local Anaesthesia
Keywords: pain control
paediatric dental patients
local anaesthesia
dentalvibe
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 41
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Intervention Model: Split-mouth assignment
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Pain felt during injection using visual analogue scale
timeFrame: Immediately after local anaesthetic delivery
Secondary outcomes:
measure: Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
timeFrame: During local anaesthesia procedure
measure: Self-reported anxiety during injection evaluated on FIS
timeFrame: Immediately after local anaesthetic delivery
measure: Heart rate dynamics of the patient
timeFrame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
measure: Assessment of self-reported dental fear on CFSS-DS questionnaire
timeFrame: Prior to each visit
measure: Patient preference to local anaesthesia method
timeFrame: One week after second procedure
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Faculty of Dental Medicine, Medical University - Plovdiv
Study officials:
affiliation: Medical University - Plovdiv, Bulgaria
name: Ani Beltcheva
role: STUDY_DIRECTOR
References:
citation: 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.