Development, Validation, and Assessment of the Diagnostic Accuracy of a Questionnaire for Periodontitis Screening (Q_ITA)

March 6, 2026 updated by: Prof. Leonardo Trombelli, Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

Sviluppo, Validazione e Determinazione Della Accuratezza Diagnostica di un Questionario Per lo Screening di Parodontite

The present study aims at validating the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire [hereafter referred to as the CDC/AAP_ITA questionnaire].

The study also aims to develop a modified version of the CDC/AAP questionnaire, enriched with additional questions, and to evaluate its diagnostic accuracy [hereafter referred to as the QSIdP questionnaire].

The study will be conducted at the Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), in collaboration with nine (9) other Italian clinical centers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The present multicenter cross-sectional clinical study aims at validateing the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire [hereafter referred to as CDC/AAP_ITA]. Furthermore, the study aims at developing a modified version of the CDC/AAP_ITA questionnaire, enriched with additional questions, and to assess its diagnostic accuracy [hereafter referred to as QSIdP].

All procedures included in the study protocol will be conducted in full compliance with the latest version of the Declaration of Helsinki. Participation in the study will require the signing of an informed consent form by each enrolled participant. In addition, the study will adhere to the STARD (Standards for Reporting Diagnostic Accuracy) guidelines.

Following development and validation, the CDC/AAP_ITA questionnaire (consisting of 8 questions) and the QSIdP questionnaire (consisting of 10 questions) will be administered to 495 patients with heterogeneous periodontal conditions recruited from ten Italian university clinical centers and/or public health facilities. Among these, Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), will be the Coordinating Center.

Within each center, patients will be enrolled according to specific inclusion criteria (i.e., age ≥18 years, ability to read and understand Italian, willingness to participate in the study) and exclusion criteria (i.e., completely edentulous individuals, subjects who have taken antibiotics within the past 3 months, pregnant women, or individuals with contraindications to periodontal probing).

Patient selection will take place during their stay in the waiting area of each participating clinical center, regardless of their chief complaint. Therefore, the questionnaires will be administered to all first-visit patients (and not exclusively to those seeking periodontal assessment).

Participants enrolled in the study will be asked to complete both the CDC/AAP_ITA and QSIdP questionnaires without external assistance. Each questionnaire will be identified by an alphanumeric code composed of the center's identifier and a progressive number. Only the principal investigator at each clinical center will hold the list linking patient names to their corresponding alphanumeric codes, thereby ensuring complete data de-identification.

Upon completion of the CDC/AAP_ITA and QSIdP questionnaires, participants will undergo a full-mouth periodontal clinical examination aimed at recording the following clinical parameters: probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BoP%). Demographic information (age, sex, body mass index), medical history (diabetes, other systemic diseases), and smoking habits will be retrieved from the patient's clinical record. In cases where this information is missing or outdated (more than six months), it will be reconfirmed with the patient. When available, radiographic information will also be integrated into the clinical data.

The clinician responsible for recording clinical parameters will then formulate a periodontal diagnosis according to two different classification systems:

i) Page & Eke, the reference standard for epidemiological studies; and ii) Tonetti et al. case definition for periodontitis.

The association between self-reported measures of periodontal disease (derived from the questionnaires) and clinical diagnosis (derived from the periodontal examination) will be analyzed using logistic regression models adjusted for potential patient-specific confounders.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
495

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients waiting in the waiting area of the participating clinical centers without a specific chief complaint.

Description

Inclusion Criteria:

  • age ≥18 years;
  • ability to read and understand Italian;
  • willingness to participate in the study

Exclusion Criteria:

  • completely edentulous individuals;
  • subjects who have taken antibiotics within the past 3 months;
  • pregnant women;
  • individuals with contraindications to periodontal probing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients receiving "CDC/AAP_ITA" and "QSIdP" questionnaire
Patients enrolled in the study (and belonging the unique examined study group) will receive the "CDC/AAP_ITA" and "QSIdP" questionnaires while waiting in the waiting room of one of the Clinical Centers. They will be instructed to complete the questionnaires independently and without assistance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: baseline visit
questionnaire ability to correctly reject healthy patients without a condition
baseline visit
sensitivity
Time Frame: baseline vist
questionnaire ability to correctly detect ill patients out of those who do have the condition
baseline vist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 532/2025/Oss/AUSLFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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