Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for bariatric surgery at a Norwegian hospital
Disqualifiers
Insufficient language skills
Lack of consent competency
Trial design
Design model
Parallel
Treatments tested in this trial
Various levels of patient education
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 4 treatment groupsGroup A: Arm 1: Group-based teachingExperimental treatment 1 intervention
Group B: Arm 2: Comparator to Arm 1Active comparator 1 intervention
Group C: Arm 3: GoodiebagExperimental treatment 1 intervention
Group D: Arm 4: Comparator to Arm 3Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Drinking habits
Reported intake plain water with no additives
Time frame
Baseline to 6 months postop. to 24 months postop.Secondary outcomes
1
Dental hygiene
Self-reported dental hygiene
Time frame
Baseline to 6 months postop. to 24 months postop.2
Level of knowledge
Knowledge reflecting the central parts of the patient education
Time frame
Baseline to 6 months postop. to 24 months postop.Other outcomes
1
Oral health
Self-reported oral health, including OHIP14
Time frame
Baseline to 6 months postop. to 24 months postop.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Helse Møre og Romsdal Hospital Trust
Collaborator
Helse Nord-Trøndelag HF
Collaborator
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov