NCT04815772

Brief Summary

The aim of present study was to evaluate how the 2018 classification reflects the severity, extent and progression of the disease, taking into account the risk factors for periodontal disease, smoking and diabetes, when compared with the 1999 classification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 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

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 19, 2021

Last Update Submit

March 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The advantages of including the effect of diabetes and smoking on periodontal disease in the 2018 classification compared to the 1999 classification

    In our study, both classifications reflected the severity of periodontal disease differently. The 2018 classification outperformed the 1999 classification for staging and grading of periodontitis severity and progression. Consideration of the risk factors listed in the 2018 classification has been useful approach for correct diagnosis, evidence-based clinical decisions, prognosis of treatment, and periodontal disease prevention. The 2018 periodontal disease classification is more detailed and comprehensive than the 1999 classification, and this classification is thought to revise the criticisms of the 1999 classification.

    The present retrospective study included individuals who were examined and had periodontal measurements made and recorded at the Istanbul Okan University Periodontology Department between 09/01/2018 and 12/01/2019.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The individuals with periodontitis who participated in the study were evaluated in three categories: * individuals who do not smoke and do not have any illnesses * non-smoking individuals with diabetes * individuals who smoke and have no systemic disease

You may qualify if:

  • Patients with a complete periodontal chart and full mouth radiographic series at baseline
  • Diabetes Mellitus:Patients who consulted by an internist/endocrinologist and underwent HbA1c measurements in the last three months.
  • Smoking status:All current smokers who had smoked more than 100 cigarettes in their lifetimes and used cigarettes for more than five years
  • Patients meeting the case definition of periodontitis
  • Relative radiographic bone loss(in %) was assessed on peri-apical radiograph films

You may not qualify if:

  • individuals with a systemic disease other than diabetes
  • Smokers not reporting the number of cigarette/days or patient(s) with diabetes that do not report Hemoglobin A1c (HbA1c) test results for diabetes.
  • individuals who do not suffer from periodontitis
  • Patients with inaccessible files because of bad debt, destroyed record, or deceased.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Okan University

Istanbul, 34947, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusSmokingPeriodontal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorMouth DiseasesStomatognathic Diseases

Study Officials

  • ekin Beşiroğlu, 1

    Okan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 25, 2021

Study Start

November 1, 2020

Primary Completion

January 30, 2021

Study Completion

March 1, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations