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

Sponsor
University of Siena (Other)
Overall Status
Recruiting
CT.gov ID
NCT04771949
Collaborator
(none)
230
1
9.3
24.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Full periodontal chart
  • Other: Questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
230 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
Actual Study Start Date :
Feb 20, 2021
Anticipated Primary Completion Date :
Nov 18, 2021
Anticipated Study Completion Date :
Nov 29, 2021

Arms and Interventions

Arm 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: 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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)

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOUS Siena Italy 53100

Sponsors and Collaborators

  • University of Siena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicola Discepoli, Researcher, University of Siena
ClinicalTrials.gov Identifier:
NCT04771949
Other Study ID Numbers:
  • LF001
First Posted:
Feb 25, 2021
Last Update Posted:
Feb 25, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2021