Anesthesia, Local
Conditions
Keywords
DentalVibe, Mandibular nerve block injection, Consolability Scale
Brief summary
The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of DentalVibe in pediatric patients.
Detailed description
This study is a crossover randomized controlled clinical trial where (N=60 ) children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. These children will be selected based on a need for local anesthesia for pulpotomy treatment on both sides of the mandible. All selected children will be randomly allocated into 2 groups. Group I (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional injection). Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment . Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).
Interventions
DEVICEDentalVibe
It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients
Topical benzocaine 20% gel on the mucosal injection site prior to injection
Sponsors
Alexandria University
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Masking description
The operator will not be blinded to the type of treatment. However, the statistician will be blinded to the treatment groups.
Intervention model description
Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period .Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment. Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age range from 5-7 years. * Patients who are in need of pulpotomy dental treatment requiring bilateral local anesthesia in the mandible. * Children free of any systemic disease or special health care needs. * Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
Exclusion criteria
* Having active sites of pathosis in the area of injection that could affect anesthetic assessment. * Signs of irreversible pulpitis or pulp necrosis. * Radiographs show periapical or bifurcation radiolucency. * Patients allergic to local anesthesia or having a family history of allergy to local anesthesia. * Patients with acute oral or facial infection (swelling and/or cellulitis). * Patients refusing to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain reduction during local anesthesia administration. | during administration of local anesthesia | Pain will be assessed during local anesthesia injection by means of Wong-Baker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful |
| Objective pain assessment after local anesthesia administration | after performing all injections | After performing all the injections, pain reaction will be evaluated by two investigators independently using recorded video tapes by Face, Leg, Activity, Cry, Consolability Scale (FLACC). The scale comprises the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0 to 2, which results in a minimum score of 0 and maximum of 10. According to this scale 0 = relaxed and comfortable (no pain), 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort or pain, A lower score represents less physical reaction than does a higher number. |
Countries
Egypt
Outcome results
None listed