Analgetic Effect of Nitrousoxide-oxygen Inhalation for De... | NCT01022294

Studies
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

NCT01022294

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 31, 2012Estimated

Enrollment

56Actual

Phase

Not Applicable

Conditions

Dental Pain
Muscle Sensitivity to Pressure
Skin Sensitivity to Electric Stimulation

Interventions

Nitrousoxide-oxygen and atmospheric air
Atmospheric air; nitrousoxide-oxygen

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 27, 2009

First Submission Date that Met QC Criteria

Nov 27, 2009

First Posted Date

Dec 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2012

Last Update Posted Date

Jan 31, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

Detailed Description

The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session	Drug: Nitrousoxide-oxygen and atmospheric air
Arm 2	Experimental	Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session	Drug: Atmospheric air; nitrousoxide-oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitrousoxide-oxygen and atmospheric air	Drug	Nitrousoxide-oxygen and atmospheric air	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dental pain (pulp) threshold		During and after inhalation

Secondary Outcomes

Measure	Description	Time Frame
Muscle sensitivity to pressure		During and after inhalation
Skin sensitivity ot electric stimulation		During and after inhalation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA-groups I or II
12-15 year of age
sound upper central incisors

Exclusion Criteria:

difficulties breathing through the nose
pregnancy
trauma to test teeth

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Poulsen, dr.odont.	Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University		Aarhus		DK-8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014098	Toothache
D000377	Agnosia
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided