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

NCT07461753 | Not Yet Recruiting

• 1 other identifier: 532/2025/Oss/AUSLFe
• Study Type: observational
• Target: 495
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontal Diseases; Periodontitis

Keywords

diagnosis; self-reported questionnaire; validation; sensitivity; specificity

Outcome Measures

Primary Outcomes (2)

• Specificity

  questionnaire ability to correctly reject healthy patients without a condition

  baseline visit

• sensitivity

  questionnaire ability to correctly detect ill patients out of those who do have the condition

  baseline vist

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy: lead

Related Publications (5)

• Montero E, La Rosa M, Montanya E, Calle-Pascual AL, Genco RJ, Sanz M, Herrera D. Validation of self-reported measures of periodontitis in a Spanish Population. J Periodontal Res. 2020 Jun;55(3):400-409. doi: 10.1111/jre.12724. Epub 2019 Dec 24.

  PMID: 31872881 BACKGROUND

• Carra MC, Gueguen A, Thomas F, Pannier B, Caligiuri G, Steg PG, Zins M, Bouchard P. Self-report assessment of severe periodontitis: Periodontal screening score development. J Clin Periodontol. 2018 Jul;45(7):818-831. doi: 10.1111/jcpe.12899. Epub 2018 May 16.

  PMID: 29611224 BACKGROUND

• Deng K, Pelekos G, Jin L, Tonetti MS. Diagnostic accuracy of self-reported measures of periodontal disease: A clinical validation study using the 2017 case definitions. J Clin Periodontol. 2021 Aug;48(8):1037-1050. doi: 10.1111/jcpe.13484. Epub 2021 Jun 1.

  PMID: 33998009 BACKGROUND

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

  PMID: 29926495 BACKGROUND

• Eke PI, Genco RJ. CDC Periodontal Disease Surveillance Project: background, objectives, and progress report. J Periodontol. 2007 Jul;78(7 Suppl):1366-71. doi: 10.1902/jop.2007.070134.

  PMID: 17610396 RESULT

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Disease; Hypersensitivity

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Central Study Contacts

Leonardo Trombelli, principal investigator

CONTACT

+39 0532 688506; leonardo.trombelli@unife.it

Anna Simonelli

CONTACT

0532 688506; anna.simonelli@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share