Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
1 other identifier
observational
230
1 country
1
Brief Summary
Periodontitis is a biofilm-mediated chronic inflammatory disease with a multi-factorial etiology; it belongs to the group of diseases classified as "Non-communicable Diseases" (NCDs). According to the results of the Global Burden of Disease Study of 2017, it is the sixth most prevalent disease worldwide and it constitutes a heavy burden on health costs. Risk factors for such disease include non-modifiable risk factors, i.e. familiarity, diabetes, cardiovascular diseases, metabolic syndrome, as well as modifiable risk factors, i.e. diet, stress and low physical exercise. Given the significant impact of oral health on the quality of life and overall well being of the individual, many studies investigated the importance of risk factors for oral health. In particular, there is some evidence that more severe manifestations of periodontitis are associated with lower physical activity (De Oliveira Ferreira et al., 2019), poor sleep quality (Karaaslan \& Dikilitaş, 2019) and more perceived stress (Coelho et al., 2020). With regards to diet, despite the high number of studies demonstrating an anti-inflammatory effect of the Mediterranean Diet, no study has ever investigated the adherence to Mediterranean Dieta to the oral health status. From a methodological standpoint, investigations regarding environmental factors are mainly carried out through questionnaires administration, whose validity and reproducibility had been previously demonstrated. The novelty introduced by the present study would be a complete analysis of the effects of lifestyles (diet, sleep quality, physical exercise, perceived stress) on the periodontal status of the individual.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2021
CompletedStudy Start
First participant enrolled
February 20, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2021
CompletedFebruary 25, 2021
February 1, 2021
9 months
February 16, 2021
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of periodontitis
The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated
Baseline
Secondary Outcomes (4)
Adherence to mediterranean diet
Baseline
Sleep Quality
Baseline
Physical Activity
Baseline
Italian Perceived Stress Scale (IPSS)
Baseline
Study Arms (1)
All patients coming to the University Clinic of Dentistry
All patients coming to the dental University Clinic will be screened for the inclusion in the study.
Interventions
A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.
After the periodontal chart, patients will be administered the italian version of 4 questionnaires regarding: 1. Adherence to Mediterranean Diet (Gnagnarella et al. 2018); 2. International Physical Activity Questionnaire (IPAQ) (Mannocci et al. 2010); 3. Pittsburgh Sleep Quality Index (PSQI) (Curcio et al. 2013); 4. Italian Perceived Stress Scale (Fossati, 2010).
Eligibility Criteria
All patients coming to the dental University clinic will be screened for the inclusion in the study
You may qualify if:
- age between 18 and 70 years old;
- ability and willingness to give informed consent.
You may not qualify if:
- pregnancy or lactation;
- inability to communicate either in English or Italian;
- inability or unwillingness to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOUS
Siena, 53100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 25, 2021
Study Start
February 20, 2021
Primary Completion
November 18, 2021
Study Completion
November 29, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02