ObesityBAR-VANNTANNNCT06617689
Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery
A study testing Various levels of patient education in people with Obesity and Bariatric Surgery Candidate, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The background for the study is that many bariatric surgery patients struggle with their oral health after bariatric surgery. This is probably related to both physiological changes and changes in eating and drinking patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Various levels of patient education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 28 Jan 2025to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for bariatric surgery at a Norwegian hospital
Who cannot join
- Insufficient language skills
- Lack of consent competency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs hospital
Trondheim
Magnus Strømmen
About this study
Official title: Effekt av Pasientundervisning på Drikkevaner og Munnhygiene Hos Pasienter Som gjennomgår Fedmekirurgi
The background for the study is that many bariatric surgery patients struggle with their oral health after bariatric surgery. This is probably related to both physiological changes and changes in eating and drinking patterns. In addition, many have reduced oral health even before surgery, and a significant proportion also have dental treatment anxiety, which also affects their ability to seek dental treatment. In sum, this is probably a patient group that may be at risk of oral pathology.
Participants in the study will be randomly allocated to different patient education programmes. The three interventions are:
Read more
- customised information on a website
- education delivered by a clinician
- distribution of free samples relevant to dental hygiene
The outcomes recorded are level of knowledge, drinking patterns, self-perceived oral health, and oral hygiene routines.
Read the detailed description
Both caries and periodontitis are more prevalent among people with obesity. At the same time, we know that bariatric surgery is associated with poorer oral health expressed by caries, enamel erosion and short-term increased inflammation in the gums. Although we do not yet have evidence to determine causality, we suspect that oral health in bariatric surgery patients is further impaired by both systemic effects (hyposalivation, altered oral microbiome, reflux and vomiting) and by altered eating and drinking patterns after surgery (acid exposure with subsequent demineralisation of tooth enamel).
The patient's own diet and oral hygiene can be an opportunity to prevent or slow down such oral problems, but requires personal effort and must be a special focus in patient education.
Patient education is one of the hospital's statutory duties, but the quality of patient education is rarely systematically investigated. This project investigates the effect of three alternative educational interventions on patients' drinking habits, oral hygiene routines, knowledge level and oral health. The three interventions are a website with adapted patient information, group-based education given by healthcare professionals, and distribution of relevant product samples to maintain oral hygiene. Patients are randomised between the different educational interventions.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Various levels of patient education
- Keywords
- Obesity, Oral health
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various levels of patient educationOther
The three interventions:
GROUP BASED TEACHING In groups of 8-12 patients, 30 minutes of standardised teaching is given. The teaching focuses in particular on the changes in diet and the impact this has on oral pH, enamel erosion and caries; recommended oral hygiene; and good drinking habits.
WEBSITE Website providing recommendations for oral hygiene and drinking habits, as well as in depth information on the topic.
DENTAL HYGIENE SAMPLES These are samples relevant for maintaining proper oral hygiene, distributed free, together with a description of how to use them.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Group-based teaching | Experimental | In this arm, all three educational activities are included: Teaching (in a group), distribution of free dental hygiene samples, and advice on reading the customised website. This arm is compared to Arm 2. Receives: Other: Various levels of patient education |
| Arm 2: Comparator to Arm 1 | Active comparator | In this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 1. Receives: Other: Various levels of patient education |
| Arm 3: Goodiebag | Experimental | In this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 4. Receives: Other: Various levels of patient education |
| Arm 4: Comparator to Arm 3 | Active comparator | In this arm, patients are adviced on reading the customised website. This arm is compared to Arm 3. Receives: Other: Various levels of patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking habits
Reported intake plain water with no additives
Measured: Baseline to 6 months postop. to 24 months postop.
Secondary outcomes (2)
Dental hygiene
Self-reported dental hygiene
Measured: Baseline to 6 months postop. to 24 months postop.
Level of knowledge
Knowledge reflecting the central parts of the patient education
Measured: Baseline to 6 months postop. to 24 months postop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start28 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Møre og Romsdal Hospital Trust, Helse Nord-Trøndelag HF, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus N Strømmen, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617689
- Sponsor's protocol ID
- 705887
- Acronym
- BAR-VANNTANN
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No