Condition category
Oral Health
Date applied
06/03/2018
Date assigned
14/03/2018
Last edited
14/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Oral health in adolescents and young adults is generally good, but there are subgroups with poor oral health, and there seems to be a strong link between socioeconomic status (SES) and oral health in adolescents and young adults. There is a need to develop more effective methods to change oral health behaviors, as conventional counseling methods are not always effective.
This study aims to investigate if a brief psychological intervention based on the acceptance and commitment therapy (ACT) is a possible way of promoting oral health, oral health behaviour and general psychological health in young adults, taking into account the individual socioeconomic status.

Who can participate?
Adults aged 18 – 25 years with two or more dental caries

What does the study involve?
Participants are randomly allocated to an intervention or control group. Both groups receive standardised oral health information, provided verbally by a registered dental nurse using a brochure on oral health behavious and caries.
Those in the intervention group also receive cognitive behavioural therapy based on acceptance and commitment therapy (ACT). This emphasises the participants own motivation to change by contacting their values and promoting committed action in line with those values. They receive two individual sessions (45 minutes each) with a licensed psychologist, delivered at their general dental clinic.

What are the possible benefits and risks of participating?
The participants may benefit from improved oral and general health. Whilst the intervention is assessed for adverse effects, no specific risks for the participants were expected.
Where is the study run from?
1. Dental Public Service Angered (Sweden)
2. Dental Public Service Vänersborg (Sweden)

When is the study starting and how long is it expected to run for?
February 2013 to May 2016

Who is funding the study?
Dental Public Service Region Västra Götaland (Sweden)

Who is the main contact?
Dr Ulla Wilde (Scientific)
ulla.wide@gu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ulla Wide

ORCID ID

http://orcid.org/0000-0001-9498-1118

Contact details

Institute of Odontology
The Sahlgrenska Academy
University of Gothenburg
P.O. Box 450
Gothenburg
405 30
Sweden
+46 31 786 3076
ulla.wide@gu.se

Type

Scientific

Additional contact

Prof Magnus Hakeberg

ORCID ID

Contact details

Institute of Odontology
The Sahlgrenska Academy
University of Gothenburg
P.O. Box 450
Gothenburg
405 30
Sweden
+46 31 7863134
hakeberg@gu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n.a.

Study information

Scientific title

Can a brief psychological intervention improve oral health behaviour?
A randomised controlled trial.

Acronym

Study hypothesis

1. A brief psychological intervention (ACT) improves oral health behaviours (such as tooth-brushing and flossing) more than standard information alone
2. A brief psychological intervention (ACT) decreases distress and improves the ability to handle life stressors more than standard information alone.

Ethics approval

Regional Ethical Review Board in Gothenburg Sweden, 03/12/2012, ref: 840-12

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Poor oral health (≥ two manifested proximal dental caries lesions)

Intervention

Participants are randomly allocated to an intervention or control group. Both groups receive standardised oral health information, provided verbally by a registered dental nurse using a brochure on oral health behavious and caries.
Those in the intervention group also receive cognitive behavioural therapy based on acceptance and commitment therapy (ACT). This emphasises the participants own motivation to change by contacting their values and promoting committed action in line with those values. It also focuses on developing their willingness to experience different negative emotions, that have previously hindered this action to occur. They receive two individual sessions (45 minutes each) with a licensed psychologist specialising in ACT, delivered at their general dental clinic.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Oral health behaviour (tooth-brushing, flossing, tooth picks, additional fluoride) was measured by a self-report questionnaire using single-questions at baseline, 3 weeks, 9 weeks, 18 weeks and 1 year.
2. Oral health (caries, gingivitis) were measured by
2.1. radiographs for manifest caries at baseline and 1 year
2.2. clinical examination for gingivitis using bleeding on probing yes/no at baseline, 9 weeks, 18 weeks and 1 year.
3. Sugar consumption was measured using a self-report questionnaire of several items for consumption of soft drinks and candy/sweets at baseline, 9 weeks, 18 weeks and 1 year.

Secondary outcome measures

1. Psychological distress and general health behaviour was assessed by a
1.1. self-report questionnaire (Hospital Anxiety and Depression Scale HADS) at baseline, 3 weeks, 9 weeks, 18 weeks and 1 year
1.2. self-report single questions (smoking, exercise) at baseline, 9 weeks, 18 weeks and 1 year.

Overall trial start date

27/02/2013

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-25 years of age
2. ≥ two manifested proximal dental caries lesions
3. Good understanding of Swedish

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Psychiatric/neuropsychiatric diagnosis, such as depression, psychosis, autism spectrum disorder, mental retardation, substance abuse.

Recruitment start date

04/10/2013

Recruitment end date

19/01/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Dental Public Service Angered
Triörgatan 2
Angered
424 65
Sweden

Trial participating centre

Dental Public Service Vänersborg
Kronogatan 14
Vänersborg
462 30
Sweden

Sponsor information

Organisation

Dental Public Service Region Västra Götaland

Sponsor details

Region Västra Götaland
Skövde
541 80
Sweden
+46 10 4417000
info.folktandvarden@vgregion.se

Sponsor type

Government

Website

https://folktandvarden.vgregion.se

Funders

Funder type

Government

Funder name

The Health Care Subcommittee, Region Västra Götaland, Sweden.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Several publications in scientific peer-reviewed journals are planned within the coming year till 31/03/2019

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Associate professor Ulla Wide at ulla.wide@gu.se

Intention to publish date

31/03/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes