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

• Status: Completed
• Trial end date: 2021-02-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Riyadh Elm University
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.