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临床试验/NCT06080672
NCT06080672已完成不适用

The Effect of Disclosing Dental Plaque on Plaque Index and Gingival Index in Istanbul Medipol University Faculty of Dentistry Students

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 124 人开始时间: 2024年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
2
主要终点
Dental examination

研究概览

简要总结

The hypothesis of this study is; using the tooth disclosing agents by individuals has a positive effect on oral care and as if it is an effective method in improving oral health. Therefore, the aim of this study is to assess the effect of visual guidance of plaque disclosing agents on plaque removal efficacy for patients versus the group of patients evaluated without any tools.

Istanbul Medipol University Faculty of Dentistry 4th grade students are going to be invited to the study. The study will carry out with a total of 124 students. The students who are systemically healthy, drug-free, and at least 20 teeth in the mouth will be included in the study. Smokers, those undergoing orthodontic treatment, the presence of pain or infection that may prevent brushing, pregnant/breastfeeding students, and students who do not agree to participate in the study will not include to the study.

After the initial records (Plaque index and Gingival Index and DMFT- caries, missing teeth due to caries, filled teeth) were obtained, the students in the study will randomly divide into 2 groups:

Group 1; Control Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, students will be asked to brush their teeth.

Group 2; Test Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, the teeth will stain with a plaque disclosing agent, the plaque is going to be shown in the mirror and then the students will brush their teeth.

Post-operatively, periodontal parameters will be evaluated. Plaque index and gingival index will be measured immediately after brushing, 1 week, 1 months are going to be compared to baseline. A single investigator will make measurements of Gingival Index (GI, Löe and Sillness-1967) and Plaque Index (PI, Sillness and Löe-1964) using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molar teeth, and the values obtained will be summed and averaged, and the average of one tooth. Then, these values will be summed up and averaged, and the mean PI and GI of the individual will be obtained. The outcomes of the two groups will be evaluated by statistical analysis.

详细描述

The study will be carried out in Istanbul Medipol University Department of Pedodontics, period between October 2023- January 2024. Ethical approval for the study was received from Istanbul Medipol University Ethics Committee. (REF: E-10840098-772.02-2361). The students who agreed to participate in the study will be informed about the study and the written informed consents will be obtained from all participants included in the study.

At the end of the study, 124 students whose measurements were completed will be included in the research. A randomization list was generated using online software (http://www.graphpad.com/quickcalcs/index.cfm), where students enrolled on the study were randomized into 2 groups with an allocation ratio of 1:1. The random allocation sequence was generated by an independent researcher; thus, the operator and observer were blinded to the assignment of the study participants to the groups as follows:

Group 1: Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth.

Group 2: The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth.

Study Design This randomized clinical study will last in three months. According to data from the previous studies, the desired sample size (n=124) was calculated. Among the 204 students who were examined in the beginning, 124 students who met the inclusion criteria will be included in the study to be protected from dropouts.

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
20 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy
  • Being drug-free
  • Have at least twenty teeth in the mouth

排除标准

  • Undergoing orthodontic treatment
  • Has pain or infection that prevent brushing
  • Pregnant/breastfeeding

结局指标

主要结局

Dental examination

时间窗: Immediately after the students filled the examination forms at the first visit

Oral and dental examination will be done by a specialist periodontist, and DMFT index (total number of decayed, filled, and missing teeth) will be recorded

Filling examination forms

时间窗: The first 10 minutes of the first visit

The form containing questions about the study group's attitudes towards oral and dental health and their demographic data is filled out by the participants.

Gingival Index (GI, Löe and Sillness-1967) measurements

时间窗: During the dental examination procedure

Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean GI of the individual will be obtained. GI will be evaluated according to the following criteria: 0: Healthy gingiva. 1. There is mild inflammation, discoloration and edema, no bleeding on probing. 2. Moderate inflammation, marked redness, edema, and bleeding on probing. 3. Severe inflammation, prominent redness and edema, ulceration, spontaneous bleeding tendency.

Plaque Index (PI, Sillness and Löe-1964) measurements

时间窗: During the dental examination procedure

Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean PI of the individual will be obtained. The PI which is going to be used to determine the oral hygiene level of the individuals included in the study will be evaluated as follows: 0: No bacterial plaque on the tooth surface. 1. There is plaque in the form of film and can be seen with the help of a probe. 2. There is moderate soft attachment visible to the naked eye. 3. There is a visible dense soft appendage filling the gingival sulcus on the tooth surface.

Green and Vermillion Oral Hygiene Index-Simplified

时间窗: 30th minute of the first visit

In the second group, to stain the teeth Mira 2-tone Solution (Hager\&Werken) will be used to visualize dental plaque. The amount of plaque will be measured by staining method from different surfaces of six teeth, two from the front area and four from the back area. 2 drops of Mira-2-tone plaque staining solution will be placed in plastic containers and be applied to the teeth with a brush. Measurements will be done from the buccal surfaces of teeth 16 and 26, the lingual surfaces of teeth 36 and 46, and the labial surfaces of teeth 11 and 31. The amount of plaque will be graded with 4 separate scores from 0 to 3, depending on the size of the surface area stained with the staining solution. The index will be calculated by dividing the total values by the number of surfaces.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilüfer Üstün

associate professor

Istanbul Medipol University Hospital

研究点 (2)

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