Dental PainNCT01022294
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
A study testing Nitrousoxide-oxygen and atmospheric air and Atmospheric air; nitrousoxide-oxygen in people with Dental Pain and Muscle Sensitivity to Pressure, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain, Muscle Sensitivity to Pressure, Skin Sensitivity to Electric Stimulation
- What is being tested?
- Nitrousoxide-oxygen and atmospheric air and Atmospheric air; nitrousoxide-oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA-groups I or II
- 12-15 year of age
- sound upper central incisors
Who cannot join
- difficulties breathing through the nose
- pregnancy
- trauma to test teeth
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University
Aarhus, DK-8000
About this study
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
Read the 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
- Being tested
- Nitrousoxide-oxygen and atmospheric air, Atmospheric air; nitrousoxide-oxygen
- Keywords
- children, analgesia, dental treatment, inhalation
- Medical subject headings
- Toothache, Agnosia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrousoxide-oxygen and atmospheric airDrug
Also called Nitrousoxide-oxygen first
Nitrousoxide-oxygen and atmospheric air
Atmospheric air; nitrousoxide-oxygenDrug
Also called Atmospheric air first
Atmospheric air; nitrousoxide-oxygen
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session Receives: 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 Receives: Drug: Atmospheric air; nitrousoxide-oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental pain (pulp) threshold
Measured: During and after inhalation
Secondary outcomes (2)
Muscle sensitivity to pressure
Measured: During and after inhalation
Skin sensitivity ot electric stimulation
Measured: During and after inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Poulsen, dr.odont., Study chair, Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022294
- Sponsor's protocol ID
- M-20070261
- Status last verified
- Jan 2012
- First submitted
- 27 Nov 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
- ClinicalTrials.gov ID
- NCT01022294
- Acronym / sponsor ID
- M-20070261
- Keywords
- children, analgesia, dental treatment, inhalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nitrousoxide-oxygen and atmospheric airInhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session |
| Arm 2 | Experimental | Drug: Atmospheric air; nitrousoxide-oxygenInhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA-groups I or II
- 12-15 year of age
- sound upper central incisors
Key exclusion criteria (3 listed)
- difficulties breathing through the nose
- pregnancy
- trauma to test teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrousoxide-oxygen and atmospheric airAlso: Nitrousoxide-oxygen firstNitrousoxide-oxygen and atmospheric air | Drug | Arm 1 |
| Atmospheric air; nitrousoxide-oxygenAlso: Atmospheric air firstAtmospheric air; nitrousoxide-oxygen | Drug | Arm 2 |
Primary outcome
Dental pain (pulp) threshold
Time frame: During and after inhalation
2 secondary outcomes
Muscle sensitivity to pressure
Time frame: During and after inhalation
Skin sensitivity ot electric stimulation
Time frame: During and after inhalation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Poulsen, dr.odont. study chair
Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrousoxide-oxygen and atmospheric air and Atmospheric air; nitrousoxide-oxygen in people with Dental Pain and Muscle Sensitivity to Pressure, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental pain (pulp) threshold (time frame: During and after inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.