A Phase 2 interventional study of DentalVibe and Topical Benzocaine 20% in Anesthesia, Local, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2020-04-10.
Sponsored by Nourhan M.Aly · Phase 2, Interventional, and Other
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.
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%).
Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 mL of Mepivacaine HCl 2%, 1/20000 Levonordefrin will be injected using a 27 gauge dental needle. DentalVibe is a small, handheld cordless device that has a charging docking station. A demonstration of DentalVibe (DV) will be performed by putting it into direct contact with the children's nails before applying the device intraorally. Then, the device will be placed on the oral mucosa to enclose the injection site before administering local anesthesia and Potential subject-expectancy effects and pressure from the placement of DV will be controlled. The device will be turned on to stimulate the area of needle penetration. After 5 seconds of vibration, the needle will be inserted. The device will continue vibrating during needle insertion and anesthetic injection.
Device: DentalVibe
Topical anesthesia -Benzocaine gel 20%. Tissues will be dried using (2 X 2) gauze to enhance the absorption of the benzocaine gel 20% around the site of the needle penetration and will be left in contact with the soft tissue for one minute. Then the local anesthetic solution (1 ml Mepivacaine HCl 2%, 1/20000 Levonordefrin) will be injected using a 27 gauge dental needle.
Drug: Topical Benzocaine 20%
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
Subjective pain reduction during local anesthesia administration.
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
Time frame: during administration of local anesthesia
Objective pain assessment after local anesthesia administration
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.
Time frame: after performing all injections
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nourhan M.Aly