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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02675387
• Other study ID #: FPGRP/43535001/163
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2016
• Last updated: February 3, 2016
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: February 2016
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Hezekiah A Mosadomi
• Phone: 0112931177
• Email: prof.mosadomi[@]riyadh.edu.sa
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry for Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Buzzy
Two minute application of a hand held vibrating device (Buzzy, MMJ labs, Atlanta GA, USA) before the administration of anesthesia

Drug:
• 2%Lidocaine
1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage)

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Colleges of Dentistry and Pharmacy	Riyadh	Al Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Jälevik 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. — View Citation

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. — View Citation

Kearl YL, Yanger S, Montero S, Morelos-Howard E, Claudius I. Does Combined Use of the J-tip® and Buzzy® 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 20 — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Pain of injection ( Wong Baker Face Pain Scale)	Pain felt measured using the Wong Baker Face Pain Scale	5 min after the injection	No
Primary	Pain of injection ( Wong Baker Face Pain Scale)	Pain felt measured using the Wong Baker Face Pain Scale	30 min after the injection	No
Secondary	Behavior ( Frankl behavior rating scale)	Behavior measured using the Frankl behavior rating scale	5min before procedure, 5 min after completion of procedure	No