NCT06617689

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. 1.customised information on a website
  2. 2.education delivered by a clinician
  3. 3.distribution of free samples relevant to dental hygiene

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable obesity

Timeline
45mo left

Started Jan 2025

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2025Dec 2029

First Submitted

Initial submission to the registry

September 26, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

September 26, 2024

Last Update Submit

July 7, 2025

Conditions

ObesityBariatric Surgery Candidate

Keywords

ObesityOral health

Outcome Measures

Primary Outcomes (1)

  • Drinking habits

    Reported intake plain water with no additives

    Baseline to 6 months postop. to 24 months postop.

Secondary Outcomes (2)

  • Dental hygiene

    Baseline to 6 months postop. to 24 months postop.

  • Level of knowledge

    Baseline to 6 months postop. to 24 months postop.

Other Outcomes (1)

  • Oral health

    Baseline to 6 months postop. to 24 months postop.

Study Arms (4)

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.

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.

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.

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.

Other: Various levels of patient education

Interventions

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.

Arm 1: Group-based teachingArm 2: Comparator to Arm 1Arm 3: GoodiebagArm 4: Comparator to Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for bariatric surgery at a Norwegian hospital

You may not qualify if:

  • Insufficient language skills
  • Lack of consent competency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs hospital

Trondheim, Norway

RECRUITING

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Magnus N Strømmen

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus N Strømmen

CONTACT

+4791701010magnus.strommen@stolav.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

September 27, 2024

Study Start

January 28, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)