The Effect of Oil Pulling on Oral Health-related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- OHIP
研究概览
简要总结
To date, there are no studies assessing the impact of mouth rinses on the oral health-related quality of life in healthy patients with gingivitis. Thus, this study aimed to assess the effect of oil pulling on the OHRQoL using the 14-item OHIP questionnaire (OHIP-14). The null hypothesis stated, that there would be no significant difference in OHIP-14 scores between individuals with gingivitis performing oil pulling with sesam-based oil and those using distilled water over an eight-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 years
- •contractual capability
- •the presence of ≥ 10 teeth,
- •community periodontal index of treatment needs (CPITN) grade 1 or 2
排除标准
- •missing consent
- •community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
- •pregnancy or breastfeeding
- •systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
- •mental and behavioral disorders that impede (verbal) communication
- •allergy against sesame(oil)
- •intake of antibiotics 6 months prior to or during study duration
- •intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
- •infectious diseases (e.g. HIV, hepatitis B or C)
- •fixed orthodontic appliances
- •ongoing oil pulling or mouth rinsing
- •adult guardianship
- •insufficient nasal breathing
研究组 & 干预措施
distilled water
8 weeks rinsing with 15ml of distilled water for 15min every morning
干预措施: distilled water (Other)
sesame oil
8 weeks oil pulling with 15 ml of sesame-based oil for 15min every morning
干预措施: sesame oil (Other)
结局指标
主要结局
OHIP
时间窗: first follow up after 4 weeks, full study duration 8 weeks
The Oral Health Impact Profile-14 (OHIP-14), a questionnaire with 14 questions, evaluates the impact of oral health on quality of life across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and speech limitation. Each of the 14 items is rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often). A total score of zero reflects the best possible oral health-related quality of life, while a score of 56 indicates the poorest. The validated German version of the questionnaire was used
次要结局
未报告次要终点
研究者
Christine Zürcher
Dr.
Medical University Innsbruck