Regimen #3 for Dental Anxiety

Phase 3

Waitlist Available

Led By Jung-Wei Chen, DDS,MS,PhD

Research Sponsored by Loma Linda University

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 change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.

Awards & highlights

Study Summary

This trial will compare the post-sedation events of three different oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients.

Eligible Conditions

Dental Anxiety
Tooth Decay

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Sedation-Related Events in Regimen #1

Incidence of Adverse Sedation-Related Events in Regimen #2

Incidence of Adverse Sedation-Related Events in Regimen #3

Secondary outcome measures

Compare incidence of adverse effect related to the use of three medications versus two medications

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Regimen 3Experimental Treatment1 Intervention

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)

Group II: Regimen 2Experimental Treatment1 Intervention

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -

Group III: Regimen 1Active Control1 Intervention

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regimen #2

2022

Completed Phase 3

~60

Regimen #3

2022

Completed Phase 3

~60