Periodontal DiseasesNCT06188884
Staging and Grading of Periodontitis: Five Years Later
An observational study of Periodontal Diseases and Periodontitis, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners
Who may be able to join
- Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners
Who cannot join
None listed.
About this study
Official title: 2018 Classification of Periodontitis Cases: Staging and Grading in Daily Dental Practice of Periodontists, Clinicians With Expertise in Periodontics and General Dental Practitioners
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:
- investigate Italian dentists' knowledge on the new classification of periodontal diseases.
- evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
- evaluate the accuracy of the use of grading in the diagnosis of periodontitis;
- evaluate diagnostic accuracy of staging application in classifying periodontitis.
Read the detailed description
Four well-documentated clincial cases will be presented to Italian dentists (Periodontists, Clinicians with Expertise in Periodontics and General Dental Practitioners) through online survey to obtain a Clinical application of the 2018 classification of periodontal diseases Each participant will be asked to diagnose periodontitis using staging and grading for each clinical case.
Each periodontal case will be documentated according a previous study (Marini et al. 2022) specifing:
Age; Systemic diseases (presence/absence); Cigarette consumption ( <10 cig/day or >10cig/day); Tooth mobility (presence/absence) Tooth migration (presence/absence) Number of tooth loss due periodontitis (0; <4; > 5) Gingival bleeding (presence/absence) Familiarity for periodontitis
Each periodontal case will be presented showing:
Intra-oral photographs; Full-mouth periapical radiographs; Periodontal chart
- Conditions
- Periodontal Diseases, Periodontitis
- Keywords
- periodontitis, classification, periodontal diseases, diagnosis
- Medical subject headings
- Periodontal Diseases, Periodontitis, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
periodontal diagnosis using I to IV stage and A to C grade.
Measured: 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
Measured: 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
Measured: at the moment of the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188884
- Sponsor's protocol ID
- NCPD
- Status last verified
- May 2024
- First submitted
- 18 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 35322458Papapanou 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.
PubMed 29926951Tonetti 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.
PubMed 29926952Marini 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.
PubMed 36083695
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2018 Classification of Periodontitis Cases: Staging and Grading in Daily Dental Practice of Periodontists, Clinicians With Expertise in Periodontics and General Dental Practitioners
- ClinicalTrials.gov ID
- NCT06188884
- Acronym / sponsor ID
- NCPD
- Conditions
- Periodontal Diseases, Periodontitis
- Keywords
- periodontitis, classification, periodontal diseases, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- investigate Italian dentists' knowledge on the new classification of periodontal diseases.
- evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
- evaluate the accuracy of the use of grading in the diagnosis of periodontitis;
- evaluate diagnostic accuracy of staging application in classifying periodontitis.
Detailed description
Four well-documentated clincial cases will be presented to Italian dentists (Periodontists, Clinicians with Expertise in Periodontics and General Dental Practitioners) through online survey to obtain a Clinical application of the 2018 classification of periodontal diseases Each participant will be asked to diagnose periodontitis using staging and grading for each clinical case.
Each periodontal case will be documentated according a previous study (Marini et al. 2022) specifing:
Age; Systemic diseases (presence/absence); Cigarette consumption ( <10 cig/day or >10cig/day); Tooth mobility (presence/absence) Tooth migration (presence/absence) Number of tooth loss due periodontitis (0; <4; > 5) Gingival bleeding (presence/absence) Familiarity for periodontitis
Each periodontal case will be presented showing:
Intra-oral photographs; Full-mouth periapical radiographs; Periodontal chart
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners
Key inclusion criteria (1 listed)
- Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
Time frame: at the moment of the diagnosis
periodontal diagnosis using I to IV stage and A to C grade.
evaluate diagnostic accuracy of the use of staging in the diagnosis of periodontitis;
Time frame: at the moment of the diagnosis
periodontal diagnosis using I to IV stage
evaluate diagnostic accuracy of the use of grading in the diagnosis of periodontitis;
Time frame: at the moment of the diagnosis
periodontal diagnosis using A to C grade
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 35322458Abrahamian 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.
- Results publication: PubMed 29926951Papapanou 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.
- Results publication: PubMed 29926952Tonetti 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.
- Results publication: PubMed 36083695Marini 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Periodontitis, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the reliability of the diagnosis between different examiners in classifying periodontitis; (time frame: at the moment of the diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188884, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.