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CompletedNCT06072742Updated Dec 1, 2023

Effect of Lifestyle on Caries and Apical Periodontitis

An observational study in Apical Periodontitis, Caries and Lifestyle, sponsored by University of Siena. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-01.

Sponsored by University of Siena · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
149
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Apical Periodontitis
  • Caries
  • Lifestyle
  • Inflammation
  • Endodontics

Keywords

  • Apical periodontitis
  • caries
  • inflammation
  • Endodontics
  • lifestyle
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 149 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Age \<18 years;
  • Pregnancy or lactation;
  • administration of antibiotics within the last 6 months;
  • Inability and unwillingness to give written consent
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
149 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    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

  2. 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

    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

  3. 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

    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

07

Study locations

1 site
  • Azienda Ospedaliera Universitaria Senese
    Siena, 53100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided — no plan to share IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06072742
Lead sponsor
University of Siena
Responsible party
Simone Grandini (Professor, University of Siena) — Principal investigator
First posted
Oct 10, 2023
Start date
Sep 20, 2020
Primary completion
Aug 20, 2021
Completion
Aug 20, 2021
Last update
Dec 1, 2023

Study contacts

Simone Grandini, DDS
study director · University of Siena

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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