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Drug

Virtual Reality vs Nitrous Oxide for Pediatric Dentistry

N/A

Recruiting

Research Sponsored by Geisinger Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will compare two methods of pediatric dental treatment: using nitrous sedation or VR goggles. Kids aged 4-12 will have either N2O or VR for their dental care.

Who is the study for?

This trial is for kids aged 4-12 who need dental work like fillings or tooth removal and can handle anesthesia. They must be in good health overall (ASA class 1 or 2). Kids with serious health issues, a high risk of seizures from lights and sounds, or those too sick for VR (ASA class 3 or 4) can't join.Check my eligibility

What is being tested?

The study tests if using a VR headset during dental treatment helps as much as laughing gas (N2O) to keep kids calm. Each child tries both methods at different visits. The Oculus Quest 2 will play videos during the procedures to distract them.See study design

What are the potential side effects?

Laughing gas might cause nausea, dizziness, or headaches in some children. Using the VR headset could lead to eye strain, motion sickness, or discomfort if worn for too long.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of effectiveness virtual reality goggles reduce pain

Secondary outcome measures

Rate of effectiveness of virtual reality distraction to nitrous oxide

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment: Virtual Reality Goggles, then Nitrous OxideExperimental Treatment2 Interventions

The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit under N2O will be used instead of VR.

Group II: Control: Nitrous Oxide, then Virtual Reality GogglesExperimental Treatment2 Interventions

Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Headset

2022

N/A

~410

Nitrous Oxide

2016

Completed Phase 4

~8380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Geisinger ClinicLead Sponsor

149 Previous Clinical Trials

1,886,073 Total Patients Enrolled

2 Trials studying Pediatric Dentistry

117 Patients Enrolled for Pediatric Dentistry

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any seniors being enrolled in this clinical inquiry?

"This medical research is recruiting participants who are 4 years old or older, but younger than 12."

Answered by AI

Am I eligible to enroll in this investigation?

"This medical experiment is in search of 62 children between the ages 4 and 12 that require two restorative procedures involving anesthesia. In addition to their age, they must also meet the American Society of Anesthesiologists (ASA) Physical Status classification 1 or 2 criteria for eligibility."

Answered by AI

Are there any available vacancies for this clinical trial?

"According to the information provided by clinicaltrials.gov, recruitment for this medical trial is ongoing; it was first published on September 19th 2023 and edited most recently on October 2nd of that same year."

Answered by AI

How many participants are included in this experiment?

"Affirmative, clinicaltrials.gov verifies that this research is still recruiting patients since its inception on September 19th 2023. 62 individuals should be recruited from only one medical site and the trial was last updated on October 2nd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality vs Nitrous Oxide in Pediatric Dentistry

2023. "Virtual Reality vs Nitrous Oxide in Pediatric Dentistry". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05890898.