NCT04960774

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

June 16, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (29)

  • probing depth (PD)

    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.

    For risk factor analysis, only the baseline is measured, which refers to the first visit

  • clinical attachment level (CAL)

    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.

    baseline

  • Number of missing teeth

    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

    baseline

  • debris index (DI-S)

    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.

    baseline

  • calculus (CI-S)

    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.

    baseline

  • simplified oral hygiene index (OHI-S)

    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.

    baseline

  • Number of defective restorations

    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.

    baseline

  • Gingival biotype

    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.

    baseline

  • Dentition crowding degree

    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

    baseline

  • Molar relationship

    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.

    baseline

  • overjet

    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

    baseline

  • overbite

    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;

    baseline

  • gender

    Divided into male and female

    baseline

  • Nation

    It is divided into Han and non-Han

    baseline

  • BMI

    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

    baseline

  • Educational level

    Senior high school ,below junior college ,undergraduate and above

    baseline

  • Economic level

    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.

    baseline

  • Mental stress

    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.

    baseline

  • Smoking

    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.

    baseline

  • History of orthodontic treatment

    Past history of orthodontic treatment , during orthodontic treatment ,no orthodontic treatment

    baseline

  • Food impaction history

    Number of food impactions in the past 6 months

    baseline

  • Bruxism / clenched teeth

    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

    baseline

  • Unilateral mastication habit

    Had the habit of chewing on one side in the past

    baseline

  • Last Dental Visit

    Includes all professional stomatologists, not just periodontists.

    baseline

  • Oral health care self-efficacy

    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.

    baseline

  • Tooth brushing

    mode, frequency, time of Tooth brushing

    baseline

  • auxiliary equipment using

    The use of other auxiliary equipment such as dental floss.Including tooth brush, tooth punch, etc., but excluding toothpicks and mouthwash

    baseline

  • Regular scaling

    the habit of cleaning teeth regularly for half a year to one year

    baseline

  • Genotypic polymorphism

    allele frequency of IL-1α-889,IL-1β +3953,IL-6-174,IL-10-597,CD14-260,CD14-159,MMP1-1607

    baseline

Study Arms (2)

Control group

Patients with non-severe periodontitis or healthy people who were treated in our department in the same period were included as the control group.

Other: Observational study, no intervention

Severe periodontitis group

Severe periodontitis patients who meet the inclusion and exclusion criteria in the Department of Stomatology, the second affiliated Hospital of Medical College of Zhejiang University

Other: Observational study, no intervention

Interventions

Observational study, no intervention

Control groupSevere periodontitis group

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

According to the CDC/AAP case definition (Page\&Eke2007/Page\&Eke2012) 1. No periodontitis is defined as no indication of mild, moderate or severe periodontitis; 2. Mild periodontitis is defined as the loss of attachment level at the adjacent site of ≥ 2 teeth ≥ 3mm and the periodontal probing depth ≥ 4mm (not on the same tooth) at the adjacent site of ≥ 2 teeth or having a site periodontal probing depth ≥ 5mm. Moderate periodontitis is defined as the loss of attachment level ≥ 4mm (not on the same tooth) at the adjacent site of ≥ 2 teeth, or periodontal probing depth ≥ 5mm (not on the same tooth) at the adjacent site of ≥ 2 teeth. Severe periodontitis is defined as the loss of attachment level at the adjacent site of ≥ 2 teeth ≥ 6mm (not on the same tooth) and the periodontal probing depth ≥ 5 mm for the adjacent site of ≥ 1 tooth position. The third molar is not included.

You may qualify if:

  • \. 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. 3. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Lihong

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Observation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 14, 2021

Study Start

April 1, 2021

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 14, 2021

Record last verified: 2021-04

Locations