Periodontal DiseasesNCT04771949
Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
An observational study of Periodontal Diseases and Periodontitis, run by University of Siena at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Lifestyle
- What is being tested?
- Full periodontal chart and Questionnaires
- How many people
- 230 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2021to 29 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: All patients coming to the dental University clinic will be screened for the inclusion in the study
Who may be able to join
- age between 18 and 70 years old;
- ability and willingness to give informed consent.
Who cannot join
- pregnancy or lactation;
- inability to communicate either in English or Italian;
- inability or unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUS
Siena, 53100
Nicola Discepoli, ndiscepoli@me.com
About this study
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
- Being tested
- Full periodontal chart, Questionnaires
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
QuestionnairesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Full periodontal chart; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of periodontitis
The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated
Measured: Baseline
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: Baseline
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)
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start20 Feb 2021
- Primary completion18 Nov 2021 (estimated)
- Study completion29 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771949
- Sponsor's protocol ID
- LF001
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04771949
- Acronym / sponsor ID
- LF001
- Conditions
- Periodontal Diseases, Periodontitis, Lifestyle, Mediterranean Diet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 18 Nov 2021 (estimated)
- Study completion
- 29 Nov 2021 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients coming to the University Clinic of Dentistry | – | Diagnostic Test: Full periodontal chart, Other: QuestionnairesAll patients coming to the dental University Clinic will be screened for the inclusion in the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients coming to the dental University clinic will be screened for the inclusion in the study
Key inclusion criteria (2 listed)
- age between 18 and 70 years old;
- ability and willingness to give informed consent.
Key exclusion criteria (3 listed)
- pregnancy or lactation;
- inability to communicate either in English or Italian;
- inability or unwillingness to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full periodontal chartA 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. | Diagnostic test | All patients coming to the University Clinic of Dentistry |
| QuestionnairesAfter 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). | Other | All patients coming to the University Clinic of Dentistry |
Primary outcome
Prevalence of periodontitis
Time frame: Baseline
The prevalence of periodontitis among a sample of patients coming to the dental University clinic will be calculated
4 secondary outcomes
Adherence to mediterranean diet
Time frame: Baseline
Sleep Quality
Time frame: Baseline
Physical Activity
Time frame: Baseline
Italian Perceived Stress Scale (IPSS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontitis, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Discepoli, DDS, MsC, PhD (0577585772, nicola.discepoli2@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of periodontitis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.