Clinical trial NCT06072742: Effect of Lifestyle on Caries and Apical Periodontitis
Official title: Effect of Lifestyle on Caries and Apical Periodontitis: Results From a University-based Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Periodontitis
Caries
Lifestyle
Inflammation
Endodontics
Keywords: Apical periodontitis
caries
inflammation
Endodontics
lifestyle
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients attending the Unit of Endodontics at the University of Siena were screened between September 2020 and August 2021. Patients were eligible based on the inclusion criteria. Individuals were included in the study after they read and signed the written informed consent, in accordance with the Declaration of Helsinki.

Brief summary: This study aimed to link lifestyle factors (Mediterranean diet adherence, stress, sleep quality, physical activity) to caries and apical periodontitis in 149 university-based individuals. Data included clinical and radiographic assessments and lifestyle questionnaires. Statistical tests and logistic regression were employed to analyze the relationships between these factors and oral health 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Apical Periodontitis
timeFrame: 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
measure: Periapical index (PAI)
timeFrame: 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
measure: Decayed, missing, filled teeth (DMFT) index
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
affiliation: University of Siena
name: Simone Grandini, DDS
role: STUDY_DIRECTOR
References: