A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.

NCT04585061 | Completed DMC

• 1 other identifier: FPGRP/2020/489/269
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the efficacy of sweet in compare to virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients. The clinical trial is a randomized split-mouth assignment. Included patients are 5 - 12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas sweet is allocated to first local anesthesia procedure and VR is allocated to second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS+sweet or CS+VR.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (1)

• Pain felt during injection using visual analogue scale

  Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.

  Immediately after local anesthetic delivery

Secondary Outcomes (4)

• Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale

  During local anesthesia procedure

• Self-reported anxiety during injection evaluated on FIS

  Immediately after local anesthetic delivery

• Heart rate dynamics of the patient

  Baseline (Start: in the waiting room), at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.

• Assessment of self-reported dental fear on CFSS-DS questionnaire

  At least 5 minutes before local anesthesia

Study Arms (2)

sweet test group

ACTIVE COMPARATOR

Local anesthesia with conventional syringe Procedure: Local anesthesia with conventional syringe + xylitol sublingual tablet Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Drug: Lidocaine Hydrochloride; Dietary Supplement: Xylitol

Virtual reality group

ACTIVE COMPARATOR

Local anesthesia with conventional syringe + VR device Device: Local anesthesia with conventional syringe + VR device Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.

Drug: Lidocaine Hydrochloride; Device: Virtual reality device (Harga Miniso Vr Glass 3d terbaru)

Interventions

Lidocaine Hydrochloride DRUG

1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle

Also known as: lignocaine

Virtual reality group; sweet test group

Virtual reality device (Harga Miniso Vr Glass 3d terbaru) DEVICE

Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon. Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized

Also known as: VR

Virtual reality group

Xylitol DIETARY_SUPPLEMENT

Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylitol tablet putted under tongue

Also known as: Xylitol candy

sweet test group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
• Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
• Children without previous experience with local anesthesia for dental treatment.
• Obtained informed consent from parents or gave-givers to participate in the study.

You may not qualify if:

• Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
• Vision requiring correction with eyeglasses.
• Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
• Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
• Patients with allergy to local anesthetics, xylitol.
• Children, who are first time ever dental patients.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

AbdulRahman Alasmari

Riyadh, 11681, Saudi Arabia

Location

Related Publications (11)

• Buchanan H, Niven N. Validation of a Facial Image Scale to assess child dental anxiety. Int J Paediatr Dent. 2002 Jan;12(1):47-52.

  PMID: 11853248 RESULT

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 RESULT

• von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.

  PMID: 16996689 RESULT

• Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006 Mar;16(3):258-65. doi: 10.1111/j.1460-9592.2005.01773.x.

  PMID: 16490089 RESULT

• ten Berge M, Veerkamp JS, Hoogstraten J, Prins PJ. Childhood dental fear in the Netherlands: prevalence and normative data. Community Dent Oral Epidemiol. 2002 Apr;30(2):101-7. doi: 10.1034/j.1600-0528.2002.300203.x.

  PMID: 12000350 RESULT

• Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. doi: 10.1016/j.jpain.2004.02.576.

  PMID: 15162342 RESULT

• Locker D, Thomson WM, Poulton R. Psychological disorder, conditioning experiences, and the onset of dental anxiety in early adulthood. J Dent Res. 2001 Jun;80(6):1588-92. doi: 10.1177/00220345010800062201.

  PMID: 11499519 RESULT

• Thomson WM, Locker D, Poulton R. Incidence of dental anxiety in young adults in relation to dental treatment experience. Community Dent Oral Epidemiol. 2000 Aug;28(4):289-94. doi: 10.1034/j.1600-0528.2000.280407.x.

  PMID: 10901408 RESULT

• Bikmoradi A, Khaleghverdi M, Seddighi I, Moradkhani S, Soltanian A, Cheraghi F. Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: A quasi-experimental study. Complement Ther Clin Pract. 2017 Aug;28:85-91. doi: 10.1016/j.ctcp.2017.05.008. Epub 2017 May 24.

  PMID: 28779942 RESULT

• Zhang C, Qin D, Shen L, Ji P, Wang J. Does audiovisual distraction reduce dental anxiety in children under local anesthesia? A systematic review and meta-analysis. Oral Dis. 2019 Mar;25(2):416-424. doi: 10.1111/odi.12849. Epub 2018 Sep 21.

  PMID: 29498793 RESULT

• Messieha Z. Risks of general anesthesia for the special needs dental patient. Spec Care Dentist. 2009 Jan-Feb;29(1):21-5; quiz 67-8. doi: 10.1111/j.1754-4505.2008.00058.x.

  PMID: 19152564 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Lidocaine; Xylitol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• AbdulRahman Alasmari, Resident

  Riyadh Elm University

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: Randomized Intervention Model: Split-mouth assignment

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: November 1, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)