Comparing inhaled nitrous oxide gas with cognitive behavioral therapy to reduce anxiety in children undergoing dental treatment
| ISRCTN | ISRCTN89346151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89346151 |
| Secondary identifying numbers | 2017-30 |
- Submission date
- 30/11/2018
- Registration date
- 07/01/2019
- Last edited
- 11/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many people become anxious when they have dental treatment. This can put them off going to the dentist regularly, which might result in teeth being in a worse condition and needing more invasive treatment. Often the anxiety stems from a stressful experience at the dentist in childhood. This study aims to compare two methods of calming children during dental treatment. Nitrous oxide can be mixed with air and inhaled through a nose mask. It reduces anxiety, pain and the gag reflex. It is safe and the effects start and wear off quickly, so the amount breathed in can be easily adjusted if the patient is in pain or feeling too woozy. Cognitive behavioural therapy (CBT) is a talking therapy that help people understand and deal with distressing feelings.
Who can participate?
Children aged 5 to 12 years who have dental anxiety and need pulp treatment in at least one molar tooth in the lower jaw.
What does the study involve?
Participants will be randomly allocated to receive nitrous oxide or CBT during the dental appointment. They will describe their anxiety levels by selecting from a set of faces before and after the dental treatment. They will also provide saliva samples before and after treatment so that levels of the stress hormone cortisol can be measured.
What are the possible benefits and risks of participating?
Patients will receive a complete dental treatment and oral health promotion as a benefit of participating in the study. All participants may leave the study any time and are informed about all the procedures that will be conducted. Nitrous oxide inhalation may provoke side effects, such as nausea or vomiting, but these effects are reversed quickly if the inhalation mask is removed.
Where is the study run from?
Universidad Austral de Chile (Chile)
When is the study starting and how long is it expected to run for?
January 2018 to December 2018
Who is funding the study?
Universidad Austral de Chile (Chile)
Who is the main contact?
1. Mrs Bruna Benso (scientific contact), bruna.benso@uc.cl
2. Mrs Claudia Mautz (public contact), cpazmautz@gmail.com
Contact information
Scientific
Marcoleta, 391
Santiago
8320000
Chile
 ORCID ID |
0000-0002-4425-5174 |
|---|
Public
Rudloff 1640
Valdivia
5090000
Chile
Study information
| Study design | Randomised parallel-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparison of nitrous oxide inhalation and cognitive behavioral therapy for anxiety in pediatric dental patients in Chile |
| Study objectives | The current study aimed to verify the safety and effectiveness of inhalation sedation with nitrous oxide when compared to cognitive behavioral therapy. |
| Ethics approval(s) | Comité de Bioética en Investigación en Humanos, Universidad Austral de Chile, 19/06/2018, ref: 007/2018 |
| Health condition(s) or problem(s) studied | Anxiety associated with dental treatment |
| Intervention | Patients who accepted the invitation were randomly allocated to the intervention A or control group B using a closed envelope technique and a block assignment of two patients. Group A received dental treatment under pharmacological sedation with a mixture of nitrous oxide in oxygen delivered by mask inhalation. Gas concentrations ranged from 30% to 70%, accordingly to patients needs. Group B received dental treatment under cognitive behavioral therapy. The cognitive behavioral therapy was a verbal 'tell–show–do' explanation of dental procedures provided before and during treatment. This is a non-pharmacological technique that allows a link to be established between the child and the dentist. All communication was constructed in phrases appropriate to the development level of the patient. Each treatment session was performed in 30-40 minutes. The total number was defined depending on their needs and according to the DMFT (decayed missing and filled teeth) caries index. All efforts were made to obtain a 1- to 2-week follow-up. |
| Intervention type | Mixed |
| Primary outcome measure | Completion of planned treatment |
| Secondary outcome measures | 1. Anxiety levels assessed using a facial image scale (FIS) immediately before the start of dental treatment and after the end of procedure 2. Stress assessed by measuring saliva cortisol levels immediately before the start of dental treatment and after the end of procedure |
| Overall study start date | 01/01/2018 |
| Completion date | 12/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 25 patients in each of the two groups |
| Total final enrolment | 49 |
| Key inclusion criteria | 1. Aged 5 to 12 years 2. Moderate to severe dental anxiety 3. Parents' consent to participate in sampling process and two sessions of dental treatment 4. At least one mandibular primary molar needing pulp treatment 5. Previous history of dental treatment |
| Key exclusion criteria | 1. Chronic obstructive pulmonary diseases 2. Acute otitis media 3. Current medications 4. Chronologically immaturity that may interfere with the ability to understand verbal communication 5. Systemic or congenital disorders 6. Mental retardation |
| Date of first enrolment | 01/07/2018 |
| Date of final enrolment | 01/12/2018 |
Locations
Countries of recruitment
- Chile
Study participating centre
Valdivia
5090000
Chile
Sponsor information
University/education
Rudloff 1640, Valdivia, Región de los Ríos
Valdivia
5090000
Chile
| Phone | +56 63 2293751 |
|---|---|
| odonto@uach.cl | |
| Website | http://medicina.uach.cl/institutos/odontoestomatologia/ |
"ROR" |
https://ror.org/029ycp228 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- DID, UACH
- Location
- Chile
Results and Publications
| Intention to publish date | 30/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to submit a results article to a peer-reviewed journal on 01/01/2019. 2019 results presented at the Chilean Division Meeting of the International Association for Dental Research (IADR) in https://iadr.abstractarchives.com/abstract/chilean-iadr2019-3264757/nitrous-oxide-sedation-reduce-sessions-and-cortisol-levels-in-children |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available upon request from Claudia Mautz, claudiamautz@uach.cl |
Editorial Notes
11/09/2020: The following changes have been made:
1. A conference abstract link has been added to the publication and dissemination plan.
2. The final enrolment number has been added from the abstract.
