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

NCT ID: NCT04771949

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2021-11-29

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.

Conditions

Periodontal Diseases; Periodontitis; Lifestyle; Mediterranean Diet

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Full periodontal chart

Intervention Type: DIAGNOSTIC_TEST

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.

Questionnaires

Intervention Type: OTHER

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).

Interventions

Full periodontal chart

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.

Intervention Type: DIAGNOSTIC_TEST

Questionnaires

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOUS

Siena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicola Discepoli, DDS, MsC, PhD

Role: CONTACT

nicola.discepoli2@unisi.it

0577585772

Facility Contacts

Nicola Discepoli

Role: primary

ndiscepoli@me.com

Other Identifiers

LF001

Identifier Type: -

Identifier Source: org_study_id