- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072742
Effect of Lifestyle on Caries and Apical Periodontitis
Effect of Lifestyle on Caries and Apical Periodontitis: Results From a University-based Cross-sectional Study
Study Overview
Status
Conditions
Detailed Description
The aim of this study was to evaluate the association between lifestyle (adherence to the Mediterranean diet, stress, sleep quality, and level of physical activity) with the presence of caries and apical periodontitis (AP) in a University-based cohort of individuals.
A total of 149 patients were included in this cross-sectional study. In addition to clinical (cold test, percussion test, evaluation of tooth mobility) and radiographic (bitewing Rx, periapical Rx, and OPT) parameters, validated questionnaires were used to investigate patient's lifestyle. Data on the number of decayed, missing, and filled teeth (DMFT score) and the severity of apical periodontitis (PAI score) were extrapolated from the available clinical and instrumental investigations. Shapiro-Wilk test was used to evaluate the normal distribution of data; Wilcoxon rank-sum test (Mann-Whitney) was used to compare continuous variables. Fisher's test was used to compare dichotomized variables. A logistic regression model was performed for the multivariate analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Siena, Italy, 53100
- Azienda Ospedaliera Universitaria Senese
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age between 18 and 70
- Good general health status;
- Ability and willingness to give written consent;
- Presence of at least 6 teeth.
Exclusion Criteria:
- Age <18 years;
- Pregnancy or lactation;
- administration of antibiotics within the last 6 months;
- Inability and unwillingness to give written consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Apical Periodontitis
Time Frame: The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
The periapical status was investigated by palpation, percussion, thermal cold testing, and panoramic radiographs.
Afterward, teeth that exhibited deep carious lesions, deep restorations, no response to pulp testing, or painful response to biting and/or percussion or palpation were suspected of AP.
Those teeth underwent further periapical radiograph using the long cone paralleling technique with a film holder.
AP cases were diagnosed based on the identification of at least one tooth with periapical radiolucency outpacing twice the width of the periodontal ligament space and having PAI > 2.
|
The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
Periapical index (PAI)
Time Frame: The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
Periapical health was assessed radiographically using the PAI score that was determined through visual inspection of the periapical area, assigning a numerical value based on the extent and severity of inflammation.
Scores ranged from 0 to 5
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The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
Decayed, missing, filled teeth (DMFT) index
Time Frame: The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
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The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Simone Grandini, DDS, University of Siena
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LS002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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