Clinical trial NCT06617689: Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery
Official title: Effekt av Pasientundervisning på Drikkevaner og Munnhygiene Hos Pasienter Som gjennomgår Fedmekirurgi
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Keywords: Obesity
Oral health
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Helse Møre og Romsdal Hospital Trust
name: Helse Nord-Trøndelag HF
name: Oslo University Hospital
First posted: 2024-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Eligible for bariatric surgery at a Norwegian hospital

Exclusion Criteria:

* Insufficient language skills
* Lack of consent competency

Primary outcomes:
measure: Drinking habits
timeFrame: Baseline to 6 months postop. to 24 months postop.
Secondary outcomes:
measure: Dental hygiene
timeFrame: Baseline to 6 months postop. to 24 months postop.
measure: Level of knowledge
timeFrame: Baseline to 6 months postop. to 24 months postop.
Other outcomes:
measure: Oral health
timeFrame: Baseline to 6 months postop. to 24 months postop.
Locations:
Study officials:
affiliation: St. Olavs Hospital
name: Magnus N Strømmen
role: PRINCIPAL_INVESTIGATOR
References: