Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
- Conditions
- Pain ManagementLocal Anaesthesia
- Interventions
- Procedure: Local anaesthesia with conventional syringeDevice: Local anaesthesia with conventional syringe + Dentalvibe
- Registration Number
- NCT03445182
- Lead Sponsor
- Plovdiv Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control group Local anaesthesia with conventional syringe Local anaesthesia with conventional syringe DentalVibe group Local anaesthesia with conventional syringe + Dentalvibe Local anaesthesia with conventional syringe + DentalVibe
- Primary Outcome Measures
Name Time Method Pain felt during injection using visual analogue scale Immediately after local anaesthetic delivery 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.
- Secondary Outcome Measures
Name Time Method Assessment of self-reported dental fear on CFSS-DS questionnaire Prior to each visit Assessment will be performed prior to both visits. The Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) questionnaire consists of 15 items related to different aspects of dental treatment, including fear of injections, scored as follows: Not afraid = 1; a little afraid = 2; fairly afraid = 3; quite afraid = 4; and very afraid = 5. Total score: 15 to 75. Children with CFSS-DS ≥32 are defined as dentally anxious.
Patient preference to local anaesthesia method One week after second procedure One week after the second dental visit, the patient is reached by a phone call and asked: "Which method do you prefer to put your tooth to sleep? With the vibrating device or without it?"
Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale During local anaesthesia procedure Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Self-reported anxiety during injection evaluated on FIS Immediately after local anaesthetic delivery The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).
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. Patient's left index finger is connected to a portable recording pulse oximeter for children.
Trial Locations
- Locations (1)
Faculty of Dental Medicine, Medical University - Plovdiv
🇧🇬Plovdiv, Bulgaria