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 Title of Study: “Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 10, 2019
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.
- 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
Arms, Groups and Cohorts
- Active Comparator: Control group
- Local anaesthesia with conventional syringe
- Active Comparator: DentalVibe group
- Local anaesthesia with conventional syringe + DentalVibe
Clinical Trial Outcome Measures
- Pain felt during injection using visual analogue scale
- Time Frame: 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.
- Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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.
- Assessment of self-reported dental fear on CFSS-DS questionnaire
- Time Frame: 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
- Time Frame: 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?”
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 8 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Plovdiv Medical University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ani Beltcheva, Study Director, Medical University – Plovdiv, Bulgaria
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