NCT06072742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

October 2, 2023

Last Update Submit

November 27, 2023

Conditions

Keywords

Apical periodontitiscariesinflammationEndodonticslifestyle

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • age between 18 and 70
  • Good general health status;
  • Ability and willingness to give written consent;
  • Presence of at least 6 teeth.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Periapical PeriodontitisInflammation

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simone Grandini, DDS

    University of Siena

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

September 20, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations