NCT04771949

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

February 16, 2021

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of periodontitis

    The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated

    Baseline

Secondary Outcomes (4)

  • Adherence to mediterranean diet

    Baseline

  • Sleep Quality

    Baseline

  • Physical Activity

    Baseline

  • Italian Perceived Stress Scale (IPSS)

    Baseline

Study Arms (1)

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 chartOther: Questionnaires

Interventions

Full periodontal chartDIAGNOSTIC_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.

All patients coming to the University Clinic of Dentistry

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).

All patients coming to the University Clinic of Dentistry

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUS

Siena, 53100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Nicola Discepoli, DDS, MsC, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 25, 2021

Study Start

February 20, 2021

Primary Completion

November 18, 2021

Study Completion

November 29, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations