Is dietary consultation an effective intervention to improve health-related behavior and oral health in adults with severe caries disease?
| ISRCTN | ISRCTN12594298 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12594298 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Gothenburg |
| Funder | The Health Care Subcommittee, Region Västra Götaland, Sweden |
- Submission date
- 11/08/2023
- Registration date
- 15/08/2023
- Last edited
- 14/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims:
Dietary factors (mainly sugars) play a crucial role for the development of caries disease. There is a need to develop more effective methods to change oral health behaviors, as conventional counseling methods are not always effective. The aim of the project is, by means of a Randomized Controlled Trial, to evaluate dietary counselling provided by a dietician, in dentistry. Can this preventive health promotive treatment change health behaviors (e.g. decreased sugar consumption) so that the risk for caries will decrease over time?
Who can participate:
Young adults (18-30 years) with caries disease (two or more manifested proximal dental caries lesions) and good understanding of Swedish.
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 hygienist using a brochure on oral health behaviour and caries. Those in the intervention group also receive manual-based dietary counselling provided by a licensed dietician, two individual sessions at the dental clinic and one booster session on telephone.
What are the possible benefits and risks of participating:
The participants may benefit from improved oral health. Whilst the intervention is assessed for adverse effects, no specific risks for the participants are expected.
Where is the study run from:
The Institute of odontology, The Sahlgrenska academy, University of Gothenburg, Sweden.
When is the study starting and how long is it expected to run for:
September 2015 to June 2022
Who is funding the study:
The Health Care Subcommittee, Region Västra Götaland, Sweden.
Who is the main contact:
Ulla Wide, licensed psychologist, professor ulla.wide@gu.se
Contact information
Scientific
PO Box 450
Göteborg
40530
Sweden
 ORCID ID |
0000-0001-9498-1118 |
|---|---|
| Phone | +46 31 786 3076 |
| ulla.wide@gu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Is a manual-based dietary intervention more effective to improve health-related behavior and particularly dietary habits, in young adults with severe dental caries disease, compared to standard information? A randomized controlled trial |
| Study objectives | A manual-based dietary intervention improves health-related behavoir, particularly dietary habits, significantly more than standard information alone |
| Ethics approval(s) |
Approved 22/04/2016, Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 10 475 08 00; registrator@etikprovning.se), ref: 185-16 |
| Health condition(s) or problem(s) studied | Poor oral health, 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 hygienist using a brochure on oral health behavior and caries. Those in the intervention group also receive a manual-based dietary intervention (two individual sessions at the clinic, one telephone booster session), provided by a licensed dietician. Duration of the intervention: two individual sessions (50 min each), one booster session (30 min). The follow-up for each arm: 6 weeks, 18 weeks, and 1 year for both study arms. Randomisation process: The randomisation was performed via a block randomisation process, and sealed envelopes. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Dietary intake and meal patterns measured using the 59-item Food Frequency Questionnaire, at baseline and 6 weeks, 18 weeks and 1 year |
| Key secondary outcome measure(s) |
1. Self-rated oral health measured with a single question, at baseline and 6 weeks, 18 weeks and 1 year |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Total final enrolment | 74 |
| Key inclusion criteria | 1. Aged 18-30 years 2. ≥2 manifest proximal dental caries lesions 3. Good understanding of Swedish |
| Key exclusion criteria | Psychiatric/neuropsychiatric diagnosis, such as depression, psychosis, autism spectrum disorder, mental retardation, substance abuse. |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 24/05/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Vänersborg
46230
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Ulla Wide at ulla.wide@gu.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/08/2024: The intention to publish date was changed from 31/12/2023 to 31/12/2024.
15/08/2023: Trial's existence confirmed by the Swedish Ethical Review Authority.
