NCT06188884

Brief Summary

The goal of this observational study is to investigate the ability of Periodontists, Clinicians with Expertise in Periodontics and General Dental Practitioners to diagnose periodontitis using the 2017 AAP / EFP World Workshop classification of periodontal diseases. The purpose of this study is to conduct a online survey in order to:

  1. 1.investigate Italian dentists' knowledge on the new classification of periodontal diseases.
  2. 2.evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
  3. 3.evaluate the accuracy of the use of grading in the diagnosis of periodontitis;
  4. 4.evaluate diagnostic accuracy of staging application in classifying periodontitis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

December 18, 2023

Last Update Submit

May 7, 2024

Conditions

Keywords

periodontitisclassificationperiodontal diseasesdiagnosis

Outcome Measures

Primary Outcomes (3)

  • evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;

    periodontal diagnosis using I to IV stage and A to C grade.

    at the moment of the diagnosis

  • evaluate diagnostic accuracy of the use of staging in the diagnosis of periodontitis;

    periodontal diagnosis using I to IV stage

    at the moment of the diagnosis

  • evaluate diagnostic accuracy of the use of grading in the diagnosis of periodontitis;

    periodontal diagnosis using A to C grade

    at the moment of the diagnosis

Eligibility Criteria

Age23 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners

You may qualify if:

  • Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Abrahamian L, Pascual-LaRocca A, Barallat L, Valles C, Herrera D, Sanz M, Nart J, Figuero E. Intra- and inter-examiner reliability in classifying periodontitis according to the 2018 classification of periodontal diseases. J Clin Periodontol. 2022 Aug;49(8):732-739. doi: 10.1111/jcpe.13618. Epub 2022 Jun 22.

  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  • Marini L, Tonetti MS, Nibali L, Sforza NM, Landi L, Cavalcanti R, Rojas MA, Pilloni A. Implementation of a software application in staging and grading of periodontitis cases. Oral Dis. 2024 Mar;30(2):719-728. doi: 10.1111/odi.14370. Epub 2022 Sep 20.

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisDisease

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor MED/28

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

June 1, 2024

Primary Completion

July 31, 2024

Study Completion

August 31, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
SAP, CSR
Time Frame
PD and any additional supporting information will become available when summary data are published.
Access Criteria
according to journal policy