Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children

Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children - A Split Mouth Randomized Clinical Trial

Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. Intervention Description

1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders
2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: 2%Lidocaine; Device: Buzzy

Detailed Description

Methodology Ethical Clearance:The study will be registered at the clinical trials registry of the United States National Institutes of Health (NIH), following which ethical approval will be obtained from the institutional review board of the Riyadh Colleges of Dentistry and Pharmacy Patient Recruitment The sample will comprise of 60 children reporting to the clinics of the Riyadh Colleges of Dentistry and Pharmacy determine to have treatment that involve the use of local anesthesia.

Sample Power Calculation Sample power calculation was done using the G Power sample size calculator (Universtat Kiel, Kiel, Germany) . Given the split mouth study design proposed a high effect size of 0.8 was assumed. The minimum number of individuals for an alpha of 0.05 and a power of 0,95 was 19 subjects per group. Given the risk of attrition of subjects in the study, the total sample size recruited will be 30 per group (n=60)

The Inclusion Criteria Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. The classification of each patient will be done separately by two experienced pediatric dentists (NG and SCP) and consensus on the classification will be obtained before including the patient in the study. Informed consent will be obtained from the parent of all patients who agree to participate in the study.

Exclusion Criteria Patients with a history of hospitalization or surgery, those with chronic illness will be excluded from the study. The study will also exclude patients diagnosed with neurobehavioral disorders such as autism, ADHD or learning disability. Patients with congenital syndromes or intellectual disability will also be excluded from the study.

Intervention Description

1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders
2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturer's recommendations to ensure that normal clinical scenario is created.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hezekiah A Mosadomi; Phone Number: 124 0112931177; Email: prof.mosadomi@riyadh.edu.sa

Study Locations

• Saudi Arabia
  • Al Riyadh
    • Riyadh, Al Riyadh, Saudi Arabia, 11681
      • Recruiting
      • Riyadh Colleges of Dentistry and Pharmacy
      • Contact: Khalid J AlAnazi; Phone Number: 0507977704; Email: khalid.alanazi@student.riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No prior experience of dental anesthesia
• At least one upper tooth on either side requiring anesthesia before restoration

Exclusion Criteria:

• History of mental illness
• Extensive hospitalization for chronic illness
• Past history of surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Group; Children will be administered buccal infiltration anesthesia using a 21mm needle and 1.8ml of 2%Lidocaine	Drug: 2%Lidocaine; 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage); Other Names: Lignocaine
Experimental: Buzzy; Children will be administered buccal infiltration anesthesia using a 21mm needle and 1.8ml of 2%Lidocaine after sensitizing the area with a vibrating device	Drug: 2%Lidocaine; 1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage); Other Names: Lignocaine; Device: Buzzy; Two minute application of a hand held vibrating device (Buzzy, MMJ labs, Atlanta GA, USA) before the administration of anesthesia; Other Names: Vibrating Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain of injection ( Wong Baker Face Pain Scale)	Pain felt on injection measured using the Wong Baker Face Pain Scale	0 min - at the time of injection
Pain of injection ( Wong Baker Face Pain Scale)	Pain felt measured using the Wong Baker Face Pain Scale	5 min after the injection
Pain of injection ( Wong Baker Face Pain Scale)	Pain felt measured using the Wong Baker Face Pain Scale	30 min after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior ( Frankl behavior rating scale)	Behavior measured using the Frankl behavior rating scale	5min before procedure, 5 min after completion of procedure

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Sharat C Pani, Riyadh Colleges of Dentistry and Pharmacy

Publications and helpful links

General Publications

• Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.
• Baxter AL, Lawson ML. Methodological concerns comparing buzzy to transilluminator device. Indian J Clin Biochem. 2014 Jan;29(1):114-5. doi: 10.1007/s12291-013-0370-8. Epub 2013 Sep 3. No abstract available.
• Shahidi Bonjar AH. Syringe micro vibrator (SMV) a new device being introduced in dentistry to alleviate pain and anxiety of intraoral injections, and a comparative study with a similar device. Ann Surg Innov Res. 2011 Jan 7;5(1):1. doi: 10.1186/1750-1164-5-1.
• Canbulat Sahiner N, Inal S, Sevim Akbay A. The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety levels in children. J Perianesth Nurs. 2015 Jun;30(3):228-35. doi: 10.1016/j.jopan.2014.05.011.
• Czarnecki ML, Turner HN, Collins PM, Doellman D, Wrona S, Reynolds J. Procedural pain management: a position statement with clinical practice recommendations. Pain Manag Nurs. 2011 Jun;12(2):95-111. doi: 10.1016/j.pmn.2011.02.003. Epub 2011 Apr 29.
• Jalevik B, Klingberg G. Pain sensation and injection techniques in maxillary dento-alveolar surgery procedures in children--a comparison between conventional and computerized injection techniques (The Wand). Swed Dent J. 2014;38(2):67-75.
• Kandiah P, Tahmassebi JF. Comparing the onset of maxillary infiltration local anaesthesia and pain experience using the conventional technique vs. the Wand in children. Br Dent J. 2012 Nov;213(9):E15. doi: 10.1038/sj.bdj.2012.988.
• Kearl YL, Yanger S, Montero S, Morelos-Howard E, Claudius I. Does Combined Use of the J-tip(R) and Buzzy(R) Device Decrease the Pain of Venipuncture in a Pediatric Population? J Pediatr Nurs. 2015 Nov-Dec;30(6):829-33. doi: 10.1016/j.pedn.2015.06.007. Epub 2015 Jul 27.
• Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.
• Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
• Whelan HM, Kunselman AR, Thomas NJ, Moore J, Tamburro RF. The impact of a locally applied vibrating device on outpatient venipuncture in children. Clin Pediatr (Phila). 2014 Oct;53(12):1189-95. doi: 10.1177/0009922814538494. Epub 2014 Jun 12.
• Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
• Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: FPGRP/43535001/163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED