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

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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

Prof Ulla Wide
Scientific

PO Box 450
Göteborg
40530
Sweden

ORCID ID	0000-0001-9498-1118
Phone	+46 31 786 3076
Email	ulla.wide@gu.se

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Dental clinic
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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 hypothesis	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
Condition	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	1. Dietary intake and meal patterns measured using the 59-item Food Frequency Questionnaire, at baseline and 6 weeks, 18 weeks and 1 year 2. Sugar consumption measured using a self-report questionnaire (items for consumption of soft drinks and candy/sweets) at baseline and 6 weeks, 18 weeks and 1 year
Secondary outcome measures	1. Self-rated oral health measured with a single question, at baseline and 6 weeks, 18 weeks and 1 year 2. Oral health-related quality of life measured with OHIP-5 (Oral health impact profile) at baseline and 6 weeks, 18 weeks and 1 year 3. Health locus of control and self-efficacy, measured with Health locus of control scale and General self-efficacy scale, at baseline and 6 weeks, 18 weeks and 1 year 4. Oral health behavior measured by a self-report questionnaire at baseline and 6 weeks, 18 weeks and 1 year 5. Psychological distress measured by EQ5D5L at baseline, 18 weeks and 1 year
Overall study start date	01/09/2015
Overall study end date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	30 Years
Sex	Both
Target number of participants	90
Total final enrolment	74
Participant inclusion criteria	1. Aged 18-30 years 2. ≥2 manifest proximal dental caries lesions 3. Good understanding of Swedish
Participant exclusion criteria	Psychiatric/neuropsychiatric diagnosis, such as depression, psychosis, autism spectrum disorder, mental retardation, substance abuse.
Recruitment start date	01/04/2019
Recruitment end date	24/05/2021

Locations

Countries of recruitment

Sweden

Study participating centre

Public dental service clinic Vänersborg, Region Västra Götaland

Kronogatan 14
Vänersborg
46230
Sweden

Sponsor information

University of Gothenburg
University/education

Box 100
Gothenburg
405 30
Sweden

Phone	+46 31 786 0000
Email	info@sahlgrenska.gu.se
Website	http://www.gu.se/english
"ROR"	https://ror.org/01tm6cn81

Funders

Funder type

Government

The Health Care Subcommittee, Region Västra Götaland, Sweden

No information available

Results and Publications

Intention to publish date	31/12/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Several publications in scientific peer-reviewed journals are planned with the coming years.
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

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.