Effect of Lifestyle on Caries and Apical Periodontitis

Inflammation Clinical Trial

Official title:

Effect of Lifestyle on Caries and Apical Periodontitis: Results From a University-based Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06072742
• Other study ID #: LS002
• Status: Completed
• Start date: September 20, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: November 2023
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apical Periodontitis
• Caries
• Endodontics
• Inflammation
• Lifestyle
• Periapical Periodontitis
• Periodontitis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Apical Periodontitis	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
Primary	Periapical index (PAI)	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	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
Primary	Decayed, missing, filled teeth (DMFT) index	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	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