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

NCT02675387 | Unknown DMC

• 1 other identifier: FPGRP/43535001/163
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Behavior ( Frankl behavior rating scale)

  5min before procedure, 5 min after completion of procedure

Study Arms (2)

Traditional Group

ACTIVE COMPARATOR

Children will be administered buccal infiltration anesthesia using a 21mm needle and 1.8ml of 2%Lidocaine

Drug: 2%Lidocaine

Buzzy

EXPERIMENTAL

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

Device: Buzzy; Drug: 2%Lidocaine

Interventions

Buzzy DEVICE

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

Also known as: Vibrating Device

Buzzy

2%Lidocaine DRUG

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

Also known as: Lignocaine

Buzzy; Traditional Group

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, Al Riyadh, 11681, Saudi Arabia

RECRUITING

Related Publications (13)

• 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.

  PMID: 24478562 RESULT

• 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.

  PMID: 21211061 RESULT

• 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.

  PMID: 24912740 RESULT

• 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.

  PMID: 26003770 RESULT

• 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.

  PMID: 21620311 RESULT

• 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.

  PMID: 25102717 RESULT

• 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.

  PMID: 23138830 RESULT

• 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.

  PMID: 26228308 RESULT

• 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.

  PMID: 19473149 RESULT

• 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.

  PMID: 21406147 RESULT

• 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.

  PMID: 24924565 RESULT

• 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.

  PMID: 24892198 RESULT

• 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.

  PMID: 30519955 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sharat C Pani

  Riyadh Colleges of Dentistry and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hezekiah A Mosadomi

CONTACT

0112931177; prof.mosadomi@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director - Pediatric Dentistry

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 5, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

SA (1)