Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery (BAR-VANNTANN)

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:

1. customised information on a website
2. education delivered by a clinician
3. 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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Other: Various levels of patient education

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus N Strømmen; Phone Number: +4791701010; Email: magnus.strommen@stolav.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • St. Olavs hospital
    • Contact: Magnus Strømmen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible for bariatric surgery at a Norwegian hospital

Exclusion Criteria:

• Insufficient language skills
• Lack of consent competency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Group-based teaching; 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.	Other: Various levels of patient education; 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.
Active Comparator: Arm 2: Comparator to Arm 1; 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.	Other: Various levels of patient education; 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.
Experimental: Arm 3: Goodiebag; 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.	Other: Various levels of patient education; 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.
Active Comparator: Arm 4: Comparator to Arm 3; In this arm, patients are adviced on reading the customised website. This arm is compared to Arm 3.	Other: Various levels of patient education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking habits	Reported intake plain water with no additives	Baseline to 6 months postop. to 24 months postop.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental hygiene	Self-reported dental hygiene	Baseline to 6 months postop. to 24 months postop.
Level of knowledge	Knowledge reflecting the central parts of the patient education	Baseline to 6 months postop. to 24 months postop.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health	Self-reported oral health, including OHIP14	Baseline to 6 months postop. to 24 months postop.

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Oslo University Hospital; Helse Nord-Trøndelag HF; Helse Møre og Romsdal Hospital Trust
• Investigators: Principal Investigator: Magnus N Strømmen, St. Olavs hospital

Publications and helpful links

Helpful Links

• Patient education website in Norwegian, English and Polish

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Oral health
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 705887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No