Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Rustogi Modified Navy Plaque index (RMNPI) scores
研究概览
简要总结
Proper plaque control is essential for to maintain oral and general health therefore, improving patient motivation is crucial for to prevent oral diseases including periodontal diseases. The aim of this clinical trial is to evaluate the effect of periodontal health education session (PHES) including the pathogenesis and consequences of periodontal diseases on oral hygiene motivation in patients with gingivitis.
详细描述
A randomized controlled clinical trial design with 50 subjects (26 Females and 24 males) was carried out in a group of gingivitis patients who underwent periodontal treatment. Subjects were randomly allocated into PHES group (test, n = 25) and standard oral hygiene education group (OHE) (control, n=25). Test group received information about the pathogenesis of periodontal diseases, its consequences, its interaction with systemic diseases and the importance of daily proper cleaning by experienced periodontologist via brochure. Control group received only standard oral hygiene instructions. The Rustogi Modified Navy Plaque index (RMNPI) and papillary bleeding index (PBI) were utilized to evaluate the oral hygiene at baseline and repeated at 1, 3 and 6 months follow-up.
The clinical outcome variables of RMNPI (primary outcome) and PBI (secondary outcome) scores were analysed with Mann Whitney U test. Friedman-Wilcoxon sign ranked test was used for within group comparison. All data were analysed using the Statistical software (SPSS, version 19.0, Chicago, IL, USA). A p-value of <0.05 was accepted as statistical significance.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A total of 50 sealed envelopes were prepared in which the group names were written. Following, they were separated in two plastic boxes equally. The group of each participant was recorded by the first author whom the educational intervention was performed (SG). The examiner who performed the clinical process (BM) was unaware of the groups
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with gingivitis (no clinical attachment loss) and no previous periodontal treatment,
- •non-smokers,
- •aged>22 years old and who have a university degree,
- •had a visible plaque level > 50%.
排除标准
- •Patients having systemic conditions that could affect the healing process and prevent the application of oral hygiene instructions,
- •Patients rehabilitated with teeth/implant supported prostheses,
- •Patients diagnosed with periodontitis,
- •Patients having defective restorations/active teeth related infection or ongoing orthodontic treatment
- •Patients who had to be out of the city in a long time during the study period.
结局指标
主要结局
Change in Rustogi Modified Navy Plaque index (RMNPI) scores
时间窗: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
The facial/lingual surfaces of each teeth was divided in nine region and scored as 0: absence of plaque and 1: existence of plaque. The averages of the sum of those scores were evaluated per patient as total (A+B+C+D), gingival margin associated (A+B+C) and interproximal region associated plaque above the margin (D+F). Furthermore, the indicator of proper interproximal cleaning surface area (A+C+D+F) was also evaluated per patient. The change in RMNPI scores between all time intervals were evaluated and compared between study groups.
次要结局
- Change in Papillary bleeding index (PBI) scores(Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.)
研究者
Sadiye Gunpinar
Asst.Prof.
Abant Izzet Baysal University