NCT00000265

Brief Summary

The purpose of this study was to characterize mood changes during nitrous oxide inhalation in patients with different levels of preoperative dental anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

4.5 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxideanxietysubjective effectsdentalpatients

Outcome Measures

Primary Outcomes (2)

  • Anxiety scale

    Before, during, after dental procedure

  • Mood scale

    Before, during, after dental procedure

Study Arms (3)

Low anxiety

Moderate anxiety

High anxiety

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

July 1, 1997

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)