Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study

• Conditions: Periodontal Diseases; Periodontitis; Lifestyle; Mediterranean Diet
• Interventions: Diagnostic Test: Full periodontal chart; Other: Questionnaires

• Registration Number: NCT04771949
• Lead Sponsor: University of Siena

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-16
• Study Start: 2021-02-20
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• age between 18 and 70 years old;
• ability and willingness to give informed consent.

Exclusion Criteria

• pregnancy or lactation;
• inability to communicate either in English or Italian;
• inability or unwillingness to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients coming to the University Clinic of Dentistry	Full periodontal chart	All patients coming to the dental University Clinic will be screened for the inclusion in the study.
All patients coming to the University Clinic of Dentistry	Questionnaires	All patients coming to the dental University Clinic will be screened for the inclusion in the study.

Primary Outcome Measures

Name	Time	Method
Prevalence of periodontitis	Baseline	The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated

Secondary Outcome Measures

Name	Time	Method
Adherence to mediterranean diet	Baseline	The secondary aim will be to relate the presence and severity of periodontitis to the adherence to Mediterranean diet, measured through a questionnaire (Gnagnarella et al. 2018) on a scale between 0 to 9. The higher the score, the higher the adherence to Mediterranean diet.
Physical Activity	Baseline	The secondary aim will be to relate the presence and severity of periodontitis to the amount of physical exercise, measured through a questionnaire (International Physical activity questionnaire, IPAQ) on a scale between 0 to 2 (0= low physical activity; 1= moderate physical activity; 2= intense physical activity)
Sleep Quality	Baseline	The secondary aim will be to relate the presence and severity of periodontitis to sleep quality, measured through a questionnaire (Pittsburgh Sleep Quality Index) on a scale between 0 to 21. The higher the score, the poorer the sleep quality.
Italian Perceived Stress Scale (IPSS)	Baseline	The secondary aim will be to relate the presence and severity of periodontitis to the amount of stress perceived, measured through a questionnaire (Italian perceived stress scale) on a scale between 0 to 40. The higher the score, the higher the amount of stress perceived.

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy