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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt av Pasientundervisning på Drikkevaner og Munnhygiene Hos Pasienter Som gjennomgår Fedmekirurgi
- ClinicalTrials.gov ID
- NCT06617689
- Acronym / sponsor ID
- BAR-VANNTANN / 705887
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- Obesity, Oral health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Helse Møre og Romsdal Hospital Trust, Helse Nord-Trøndelag HF, Oslo University Hospital
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Group-based teaching | Experimental | Other: Various levels of patient educationIn 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. |
| Arm 2: Comparator to Arm 1 | Active comparator | Other: Various levels of patient educationIn this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 1. |
| Arm 3: Goodiebag | Experimental | Other: Various levels of patient educationIn this arm, patients are distributed free dental hygiene samples, and given advice on reading the customised website. This arm is compared to Arm 4. |
| Arm 4: Comparator to Arm 3 | Active comparator | Other: Various levels of patient educationIn this arm, patients are adviced on reading the customised website. This arm is compared to Arm 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible for bariatric surgery at a Norwegian hospital
Key exclusion criteria (2 listed)
- Insufficient language skills
- Lack of consent competency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Various levels of patient educationThe 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. | Other | Arm 1: Group-based teaching, Arm 2: Comparator to Arm 1, Arm 3: Goodiebag, Arm 4: Comparator to Arm 3 |
Primary outcome
Drinking habits
Time frame: Baseline to 6 months postop. to 24 months postop.
Reported intake plain water with no additives
2 secondary outcomes
Dental hygiene
Time frame: Baseline to 6 months postop. to 24 months postop.
Level of knowledge
Time frame: Baseline to 6 months postop. to 24 months postop.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Patient education website in Norwegian, English and PolishLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magnus N Strømmen principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus N Strømmen (+4791701010, magnus.strommen@stolav.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking habits (time frame: Baseline to 6 months postop. to 24 months postop.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.