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NCT Number: NCT03445182

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

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.

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Key information

Conditions

Pain Management Agnosia Local Anaesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Medical University - Plovdiv

Plovdiv, 4000, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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?"

Sponsors and collaborators

Lead sponsor

Plovdiv Medical University

Other

Registry information

Official study title

Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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