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

February 23, 2021 updated by: Nicola Discepoli, University of Siena

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients coming to the dental University clinic will be screened for the inclusion in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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:

  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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of periodontitis
Time Frame: Baseline
The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to mediterranean diet
Time Frame: 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.
Baseline
Sleep Quality
Time Frame: 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.
Baseline
Physical Activity
Time Frame: 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)
Baseline
Italian Perceived Stress Scale (IPSS)
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Anticipated)

November 18, 2021

Study Completion (Anticipated)

November 29, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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