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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771949
• Other study ID #: LF001
• Status: Recruiting
• Start date: February 20, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: February 2021
• Source: University of Siena
• Contact: Nicola Discepoli, DDS, MsC, PhD
• Phone: 0577585772
• Email: nicola.discepoli2[@]unisi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: November 29, 2021
• Est. primary completion date: November 18, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lifestyle
• Mediterranean Diet
• Periodontal Diseases
• Periodontitis

Intervention

Diagnostic Test:
• 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.

Other:
• Questionnaires
After the periodontal chart, patients will be administered the italian version of 4 questionnaires regarding: Adherence to Mediterranean Diet (Gnagnarella et al. 2018); International Physical Activity Questionnaire (IPAQ) (Mannocci et al. 2010); Pittsburgh Sleep Quality Index (PSQI) (Curcio et al. 2013); Italian Perceived Stress Scale (Fossati, 2010).

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of periodontitis	The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated	Baseline
Secondary	Adherence to mediterranean diet	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.	Baseline
Secondary	Sleep Quality	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.	Baseline
Secondary	Physical Activity	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)	Baseline
Secondary	Italian Perceived Stress Scale (IPSS)	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.	Baseline