Condition category
Mental and Behavioural Disorders
Date applied
30/11/2018
Date assigned
07/01/2019
Last edited
07/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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


Trial website

Contact information

Type

Scientific

Primary contact

Mrs Bruna Benso

ORCID ID

http://orcid.org/0000-0002-4425-5174

Contact details

Marcoleta
391
Santiago
8320000
Chile

Type

Public

Additional contact

Mrs Claudia Mautz

ORCID ID

Contact details

Rudloff 1640
Valdivia
5090000
Chile

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2017-30

Study information

Scientific title

Comparison of nitrous oxide inhalation and cognitive behavioral therapy for anxiety in pediatric dental patients in Chile

Acronym

Study hypothesis

The current study aimed to verify the safety and effectiveness of inhalation sedation with nitrous oxide when compared to cognitive behavioral therapy.

Ethics approval

Comité de Bioética en Investigación en Humanos, Universidad Austral de Chile, 19/06/2018, ref: 007/2018

Study design

Randomised parallel-arm trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/01/2018

Overall trial end date

12/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

25 patients in each of the two groups

Participant 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

Recruitment start date

01/07/2018

Recruitment end date

01/12/2018

Locations

Countries of recruitment

Chile

Trial participating centre

Universidad Austral de Chile
Rudloff 1640, Valdivia, Región de los Ríos
Valdivia
5090000
Chile

Sponsor information

Organisation

Universidad Austral de Chile

Sponsor details

Rudloff 1640
Valdivia
Región de los Ríos
Valdivia
5090000
Chile
+56 63 2293751
odonto@uach.cl

Sponsor type

University/education

Website

http://medicina.uach.cl/institutos/odontoestomatologia/

Funders

Funder type

Government

Funder name

Dirección de Investigación, Universidad Austral de Chile

Alternative name(s)

DID, UACH

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Chile

Results and Publications

Publication and dissemination plan

We plan to submit a results article to a peer-reviewed journal on 01/01/2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available upon request from Claudia Mautz, claudiamautz@uach.cl

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes