Behavioral Intervention Program Based on Motivational Interview to Improve Oral Hygiene in Adults - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The change in Bleeding on Probing to evaluate the improvement in hygiene behavior
研究概览
简要总结
The best way for dental professionals act using dialogue methods and individual approaches in daily clinical practice to change behavioral is still inconclusive. Thus, the objective will be evaluate the effect of using motivational interviewing as part of the treatment of periodontitis in order to increase the adherence of adults to adequate oral health behavior.
详细描述
Patient-related approaches may show better results in treatment of periodontal diseases. The best way for the dental surgeon to act using these methods is still inconclusive. The aim of this study is to evaluate the effectiveness of using motivational interviewing as part of the treatment of periodontitis in order to increase adult adherence to adequate oral health behavior. A randomized clinical trial, with a sample size of at least 72 subjects, >18 years of age and with at least 18 teeth, will be investigated. Individuals in the test group will receive a collaborative communicative approach, inspired by the motivational interview, while the control group will receive the information/instructions in a conventional approach. The efficacy variables for evaluating the pattern of self-control of periodontal infection will be the bleeding on probing (BoP), gingival index (GI, primary efficacy variable), the plaque index (PI) and patient-based outcomes will be assessed using quality of life questionnaires. Additionally, questionnaires will be applied to obtain sociodemographic, behavioral and self-perception of oral health data. Univariate and multivariate analyzes will be performed and conducted in the Statistical Products Service Solutions software (SPSS, version 25). Thus, it will be possible to assess whether brief oral health education interventions centered on the individual can be used by dental surgeons in order to effectively improve oral hygiene behaviors in adults, obtaining better clinical results and a better quality of life for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Adults, over 18-year-old;
- •BoP (Bleeding on probing) in at least 30% of sites;
- •Diagnosed periodontitis.
排除标准
- •Diabetes;
- •Pregnancy (or the planning of pregnancy);
- •Immunosuppressive illness or a medication, hepatitis, HIV, a bleeding illness or a anticoagulant;
- •A need for the antibiotic prophylaxis;
- •Hyposalivation or use of medications that cause hyposalivation
结局指标
主要结局
The change in Bleeding on Probing to evaluate the improvement in hygiene behavior
时间窗: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
BoP - Dichotomic response after probing the gingival sulcus. High values mean worst condition.
The change in Gingival index to evaluate the improvement in hygiene behavior
时间窗: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
GI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
The change in Plaque Index to evaluate the improvement in hygiene behavior
时间窗: baseline, 15 days after supragingival treatment, 30 and 60 days after subgingival treatment and through study completion, an average of 1 year
PI - Each of the 6 sites of the tooth is given a score from 0 to 3. High values mean worst condition.
Patient satisfaction assessed by the change in Quality of Life questionnaire
时间窗: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Quality of life - % of patients with better scores (lowest values) of quality of life. It can vary from 0 to 56.
Patient perception assessed by the change in autoperception of oral health questionnaire
时间窗: baseline, 60 days after subgingival treatment and through study completion, an average of 1 year
Autoperception of oral health - rate of patients with better condition of oral health perception. The answer options are: Great; Good; Regular; Bad; Terrible. 0-4 (lower scores mean better self-perception).
次要结局
- Oral hygiene-related self-efficacy assessed by the oral hygiene-related selfefficacy (OHSE) questionnaire(60 days after subgingival treatment and six months later)
研究者
Carlos Heitor Cunha Moreira
Principal Investigator
Universidade Federal de Santa Maria