跳至主要内容
临床试验/NCT06617689
NCT06617689招募中不适用

Effekt av Pasientundervisning på Drikkevaner og Munnhygiene Hos Pasienter Som gjennomgår Fedmekirurgi

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Drinking habits

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible for bariatric surgery at a Norwegian hospital

排除标准

  • •Insufficient language skills
  • •Lack of consent competency

研究组 & 干预措施

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.

干预措施: Various levels of patient education (Other)

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.

干预措施: Various levels of patient education (Other)

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.

干预措施: Various levels of patient education (Other)

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.

干预措施: Various levels of patient education (Other)

结局指标

主要结局

Drinking habits

时间窗: Baseline to 6 months postop. to 24 months postop.

Reported intake plain water with no additives

次要结局

  • Dental hygiene(Baseline to 6 months postop. to 24 months postop.)
  • Level of knowledge(Baseline to 6 months postop. to 24 months postop.)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of Patient Education on Drinking Behaviour... | 临床试验