Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery

NCT ID: NCT06617689

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2029-12-31

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Various levels of patient education

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Various levels of patient education

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Various levels of patient education

Intervention Type: OTHER

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.

Arm 4: Comparator to Arm 3

In this arm, patients are adviced on reading the customised website. This arm is compared to Arm 3.

Group Type: ACTIVE_COMPARATOR

Various levels of patient education

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Eligible for bariatric surgery at a Norwegian hospital

Exclusion Criteria

• Insufficient language skills
• Lack of consent competency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Møre og Romsdal Hospital Trust

UNKNOWN

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus N Strømmen

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

St. Olavs hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Magnus N Strømmen

Role: CONTACT

magnus.strommen@stolav.no

+4791701010

Facility Contacts

Magnus Strømmen

Role: primary

Related Links

http://www.bar-oral.no

Patient education website in Norwegian, English and Polish

Other Identifiers

705887

Identifier Type: -

Identifier Source: org_study_id