A Randomized Clinical Field Study on Behavioral Interventions to Increase Adolescent's Motivation for Self Performed Periodontal Infection Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Marginal gingival bleeding index
研究概览
简要总结
This study evaluates behavioral interventions to increase adolescent's motivation for self performed periodontal infection control, by means of adequate oral hygiene. Study subjects will be allocated to test and control group where the test will be subjected to an individually tailored oral health education program, based on cognitive- behavioral theory and principles, and the control to standard educational intervention.
详细描述
The prevalence of chronic periodontitis is about 40% among the Swedish adult population. The key-factor for the prevention of periodontal disease progression is the establishment of periodontal infection control, by means of adequate daily oral hygiene. Hence, a main task for dental professionals is to educate and motivate the patient to such beneficial behavior. A hypothesis for the current study is that patient centered health promotion programs based on cognitive behavioral theory and principles and with a directive communicative approach, i.e. motivational interviewing techniques, add positive and lasting effects to standard educational interventions on self-performed periodontal infection control.
This randomized clinical field study involves 30 professionals (dental hygienists) and about 350 adolescent patients at 16 dental clinics in the Västra Götaland Region, Sweden. The approach in the evaluation is on patient-centered outcomes and health economics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 or 17 years old at inclusion
- •poor oral hygiene conditions (dental plaque and/or marginal gingival bleeding at >50% of tooth surfaces) at the time of examination and thus considered to be at increased risk for oral/periodontal disease progression.
排除标准
- •compromised medical or mental conditions that may requiring special care.
研究组 & 干预措施
Patient centered oral health education
The program is based on cognitive behavioral theory and principles. Hence, the intervention is adapted to each individual's problem, capacity and goals were the dental hygienist use motivational interviewing skills in communication and act as a guiding resource during the process of behavioral change. The program follows a specific structure including components such as formulation of personal goals, continuous self-monitoring by diary and planning of behavior. The initial intervention phase contain 3 treatment sessions (45-60 min each) during a period of 12 weeks (baseline, 2-3 weeks and 10-12 weeks). Follow up are performed at 6- and 18-months.
干预措施: Patient centered oral health education (Behavioral)
Standard educational intervention
The subjects in the control group receive educational intervention by a dental hygienist in accordance with conventional routines (oral health information and oral hygiene instruction at one or several occasions). Follow up are performed at 6- and 18-months.
干预措施: Standard educational intervention (Behavioral)
结局指标
主要结局
Marginal gingival bleeding index
时间窗: Up to 18-months
Percentage of tooth-surfaces with bleeding (infection) at clinical examination
次要结局
- Patient reported outcome measures (PROM)(Up to 18-months)
- Individual investment for treatment - Direct and subsidiary costs(Up to 18-months)
- Patient reported experience measures (PREM)(Up to 18-months)