Human Subject Research Ethics Committee, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Tooth brushing
研究概览
简要总结
Periodontitis is one of the most common oral diseases, which is characterized by alveolar bone resorption and destruction. In China, as a major country in the incidence of periodontitis, there is a huge population of patients with severe periodontitis, and the incidence rate is as high as 12.1-16.1% . Previous studies have suggested that the prevalence and severity of periodontal disease increase with age. However, recent articles on meta analysis and related epidemiological investigations suggest that the prevalence of severe periodontitis does not increase with age, and the prevalence of SP remains at about 10% even in the elderly. In order to comprehensively analyze the risk factors of this population, it is inseparable from the analysis of gene polymorphism. At present, it is considered that the main genes that may be related to the severity of periodontitis are IL-1 α-889, rhIL-talk 1 β + 3953, 6-174, 10-597, CD14-260, CD14-159, MMP1-1607 and so on, which may be related to the severity of periodontitis.
详细描述
Periodontitis is one of the most common oral diseases, which is characterized by alveolar bone resorption and destruction. In 2010, severe periodontitis (severe periodontitis,SP) had become the sixth largest epidemic disease in the world, affecting 10.8% of the global population or 743 million people . In China, as a major country in the incidence of periodontitis, there is a huge population of patients with severe periodontitis, and the incidence rate is as high as 12.1-16.1% . The fourth National Oral Health Epidemiological Survey also found that the oral health of residents aged 35-44 is generally poor , which has become a major obstacle to the implementation of the "Healthy China 2030" strategy. Previous studies have suggested that the prevalence and severity of periodontal disease increase with age . The possible reasons for this phenomenon are as follows.First, the cumulative effect of attachment level and bone loss with age.Second, changes related to the aging process, such as drug intake, decreased immune function, and changes in nutritional status interact with risk factors can increase the susceptibility to periodontitis. However, recent articles on meta analysis and related epidemiological investigations suggest that the prevalence of severe periodontitis does not increase with age, and the prevalence of SP remains at about 10% even in the elderly. In addition, the global meta analysis with large sample size showed that the prevalence of SP increased sharply between 30 and 40 years old, peaked at about 38 years old. This trend of severe periodontitis with age is not consistent with our traditional cognition, and there is no related research to explain this trend. However, it is found that 30-40 years old patients with severe periodontitis account for a large proportion, so it is of great significance to analyze the risk factors of this group and carry out targeted prevention and control. In order to comprehensively analyze the risk factors of this population, it is inseparable from the analysis of gene polymorphism. Studies related to severe periodontitis gene polymorphism are mainly focused on Toll-like receptor (Toll-likereceptors), interleukin (interleukin,IL), immunoglobulin receptor (Immunoglobulinreceptors), formyl peptide receptor (Formylpeptide receptor), vitamin D receptor (VitaminDreceptor, VDR) and matrix metalloproteinases (matrixmetalloproteinase,MMP). At present, it is considered that the main genes that may be related to the severity of periodontitis are IL-1 α-889, rhIL-talk 1 β + 3953, 6-174, 10-597, CD14-260, CD14-159, MMP1-1607 and so on, which may be related to the severity of periodontitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients aged between 30 and 40 years old were diagnosed with severe periodontitis and were treated for the first time, while those in the control group were patients with non-severe periodontitis or healthy people. All the subjects had complete basic information, questionnaire data and clinical examination data.
- •The patient's thinking is clear, there is no barrier to communication, and can cooperate to complete the questionnaire. 4.In addition, the genetic polymorphism test required that the three generations were all Han nationality, with no history of orthodontic treatment, no obvious malocclusion and local stimulating factors, and no Systemic disease (including diabetes, cardiovascular disease, hepatitis, HIV infection, etc.), non-smoking or non-smoking for more than 5 years
排除标准
- •Patients suspected to be invasive periodontitis, the plaque level and the degree of periodontal destruction are disproportionate.
- •Systemic diseases (including diabetes, cardiovascular disease, hepatitis, HIV infection, etc.)
- •Pregnant women, women who are pregnant, lactating or mentally ill. 4.Those who are taking known drugs that affect periodontal tissue or have a history of antibacterial treatment within 6 months. 5.Those who have a history of periodontal treatment within 6 months are excluded. 6.In addition, testing for genetic polymorphism required the exclusion of malignancies or those who had undergone radiotherapy or chemotherapy
结局指标
主要结局
Tooth brushing
时间窗: baseline
mode, frequency, time of Tooth brushing
probing depth (PD)
时间窗: For risk factor analysis, only the baseline is measured, which refers to the first visit
The distance from the bottom of the periodontal pocket to the gingival margin (mm) was measured with a periodontal probe (UNC-15, Hu-Friedy, Chicago) parallel to the long axis of teeth. 6 sites including mesial, median and distal on the lips (cheek) and tongue surfaces were recorded for each tooth.
clinical attachment level (CAL)
时间窗: baseline
The distance from the gingival crevicular floor or periodontal pocket floor to the enamel bone boundary was measured by periodontal probe. The mesial, median and distal sites of the labial (buccal) surface and tongue surface of each tooth were measured.
debris index (DI-S)
时间窗: baseline
The oral cavity was divided into 6 segments, and the debris of 6 index teeth was examined: 16, 26, 36, 46, 11, 31; if missing, check the adjacent teeth in the same area. The values are as follows: 0 = there is no debris on the tooth surface; 1 = the debris coverage area is less than 1/3; 2 = the debris coverage area is between 1/3 and 2/3; 3 = the debris coverage area accounts for more than 2/3 of the tooth surface.
calculus (CI-S)
时间窗: baseline
The examination method is the same as above, check the calculus condition of 6 index teeth. The assigned values are as follows: 0 = no supragingival and subgingival calculus; 1 = the area covered by supragingival calculus is less than 1 / 3 of the tooth surface; 2 = the area covered by supragingival calculus is between 1 / 3 and 2 / 3, or there are scattered subgingival calculi in the neck; 3 = the area covered by supragingival calculus accounts for more than 2 / 3 of the tooth surface, or there are continuous and thick subgingival calculus in the neck.
simplified oral hygiene index (OHI-S)
时间窗: baseline
The sum of the 6 CI-S or DI-S, choose the larger one. 0HI-S ≥ 10 means poor oral hygiene. OHI \< 10 is good for oral hygiene.
Dentition crowding degree
时间窗: baseline
The crowding degree of the canine-canine area of the lower anterior teeth can be easily evaluated according to the crowding degree of the canine-canine area of the lower anterior teeth, which can be divided into the following four grades : 0 = none, 1 = the crowding degree of the lower anterior teeth is equal to half the width of the lower central incisor, 2 = the crowding degree of the lower anterior teeth is equal to the width of a central incisor, 3 = the crowding degree of the lower anterior teeth exceeds the width
Number of missing teeth
时间窗: baseline
Refers to the number of missing teeth except the third molar Refers to the number of missing teeth except the third molar Refers to the number of missing teeth except the third molar Refers to the number of missing teeth except the third molar
Number of defective restorations
时间窗: baseline
It means that the crown edge of the restoration is located under the gingiva, the surface of the restoration is rough, the degree of fit with the tooth surface is not good, the shape is too convex, the contact area, marginal ridge recovery is not good, and so on. Among them, the fixed bridge is calculated according to the number of teeth of the bad bridge.
Molar relationship
时间窗: baseline
Angle class I: the occlusion of the mesiobuccal tip of the maxillary first molar is neutral with the molar in the mesiobuccal groove of the mandibular first permanent molar; Angle II: the distance of the mandibular retreating 4 molars or half of the premolars, the distance of the molars is distal; Angle III: the distance of the mandibular forward movement of at least 1x4 molars or half of the premolars, and the molars are mesial.
overjet
时间窗: baseline
The horizontal distance from the incisor edge of the upper incisor to the labial surface of the lower incisor. The distance within 3mm is normal coverage, 3mm \< coverage ≤ 5mm is I-degree deep coverage, 5mm \< coverage ≤ 8mm is II-degree deep coverage, and coverage \> 8mm is III-degree deep coverage
gender
时间窗: baseline
Divided into male and female
Economic level
时间窗: baseline
The measure of economic level is reflected by the per capita monthly income of the family = the total monthly income of the family / the number of people in the family.
Mental stress
时间窗: baseline
Mental stress is measured by Perceptual Stress Scale.The scale makes necessary changes to the overall structure and specific items of PSS to make the content more in line with China's national conditions. CPSS consists of 14 items, which are composed of two dimensions: the sense of tension and the sense of loss of control. Using Likert's five-point scoring system, 1 means "never", 2 means "occasionally", 3 means "sometimes", 4 means "often" and 5 means "always". The total score of the scale ranges from 14 to 70, and the higher the score, the greater the perceived pressure.
History of orthodontic treatment
时间窗: baseline
Past history of orthodontic treatment , during orthodontic treatment ,no orthodontic treatment
Unilateral mastication habit
时间窗: baseline
Had the habit of chewing on one side in the past
Last Dental Visit
时间窗: baseline
Includes all professional stomatologists, not just periodontists.
auxiliary equipment using
时间窗: baseline
The use of other auxiliary equipment such as dental floss.Including tooth brush, tooth punch, etc., but excluding toothpicks and mouthwash
Gingival biotype
时间窗: baseline
According to the judgment method proposed by Kan et al, and combined with the clinical practice of our country, the periodontal biotypes are divided into the following three types: 1. Thick gingiva:. Examination methods: the outline of the periodontal probe into the gingival sulcus is completely unrecognizable at the gingival margin and through the gingival tissue at the front of the probe; 2. Thin gingiva: Examination method: the outline of the periodontal probe into the gingival sulcus can be recognized at the gingival margin and through the gingival tissue at the front of the probe . 3. Intermediate gingiva: the characteristic is between the above two; examination method: the outline of the periodontal probe into the gingival sulcus can be identified at the gingival margin through the gingival tissue, while the front part of the probe cannot be identified.
Nation
时间窗: baseline
It is divided into Han and non-Han
BMI
时间窗: baseline
Body mass index ((BMI)) = weight (kg) / height (m) squared according to the guidelines for the Prevention of overweight and Obesity in Chinese Adults \[1\]: BMI \< 18.5 kg/m2 is weight loss 18.5 kg/ m2 \< 24.0 kg/m2 is normal 24.0 kg/ m2 \< 28.0 kg/m2 is overweight BMI ≥ 28.0 kg/m2 is obese
overbite
时间窗: baseline
The front teeth cover the front teeth covering no super cut 1/3 and the lower teeth cutting in front of the front terture tongue is 1/3, and it is normal to cover it; I degree deep cover: up to teeth cover The lower teeth are more than 1/3 and less than 1/2 or lower tooth dumps are biting in front tootooth, and less than 1/3 and less than 1/2; II degree deep cover: up to teeth Over the previous lip surface exceeds the cut 1/2 and less than 2/3 or the until the until the front teeth are above the front tootooth tongue, the tongue is less than 2/3; III degree deep cover: upper teeth Override overhead lip surfaces exceed 2/3 or lower teeth in the front tooth tongue more than 1/3;
Educational level
时间窗: baseline
Senior high school ,below junior college ,undergraduate and above
Food impaction history
时间窗: baseline
Number of food impactions in the past 6 months
Smoking
时间窗: baseline
Smoking status is constructed by two questions in the questionnaire: subjects who smoke every day or a few days and smoke more than 100 cigarettes; former smokers: subjects who do not smoke at present but have smoked more than 100 cigarettes in the past; non-smokers: subjects who smoked no more than 100 cigarettes.
Bruxism / clenched teeth
时间窗: baseline
Whether others tell or feel that they are grinding and / or clenching their teeth during sleep; or whether there is unconscious clenching and / or grinding during the day
Oral health care self-efficacy
时间窗: baseline
Oral health self-efficacy was evaluated by Wu Di's Chinese oral health self-efficacy scale.A total of 15 items in this scale are divided into 3 dimensions, namely, oral self-efficacy, correct tooth brushing self-efficacy and balance, diet self-efficacy. Using the likert5 score scale, the score was from 1 (no confidence at all) to 5 (very confident). The total score was 15-75, in which the score was 15-53 as low performance, 54-59 as medium performance, and 60-75 as high performance. The higher the score, the higher the level of oral health self-efficacy.
Regular scaling
时间窗: baseline
the habit of cleaning teeth regularly for half a year to one year
Genotypic polymorphism
时间窗: baseline
allele frequency of IL-1α-889，IL-1β +3953，IL-6-174，IL-10-597，CD14-260，CD14-159，MMP1-1607
次要结局
未报告次要终点