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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03779763
Other study ID # 21252461
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2019
Est. completion date September 15, 2019

Study information

Verified date July 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III & IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University


Description:

Since the 1999 workshop, substantial new information has emergedfrom population studies, basic science investigations, and evidencefrom prospective studies evaluating environmental and systemic riskfactors. The analysis of this evidence has prompted the 2017 workshopto develop a new classification framework for periodontitis

In the last 30 years, the classification of periodontitis has been repeatedly upgraded in an attempt to align it with emerging scientific evidence. The workshop agreed that, consistent with current knowledge on pathophysiology, three forms of periodontitis can be identified: necrotizing periodontitis, periodontitis as a manifestation of systemic disease and the forms of the disease previously known as "chronic" or "aggressive", now grouped under a single category, "periodontitis".In revising the classification, the workshop agreed on a classification framework for periodontitis further characterized based on a multidimensional staging and grading system that could be adapted over time as new evidence emerges

Staging is largely dependent upon the severity of disease at presentationas well as on the complexity of disease management.While,grading provides supplemental information about biological features of the disease, including a history based analysis of the rate of disease progression, assessment of the risk for further progression, anticipated poor outcomes of treatment, and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient

Staging involves four categories (stages 1 through 4) and is determined after considering several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects, furcation involvement,tooth mobility and tooth loss due to periodontitis.

Stage III & IV are characterized by interdental clinical attatchment loss > 5mm and radiographic bone loss extending to the middle or apical third of the root. In stage III, four teeth or less are lost while in stage IV, five teeth or more are lost due to periodontitis. In addition to stage II complexity, Stage III is characterized by probing depth greater than or equal 6 mm, vertical bone loss greater than or equal 3mm, furcation involvement class II or III and moderate ridge defect. In addition to stage III complexity, stage IV is characterized by severe ridge defect , bite collapse, drifting and flaring.

The study aims at determining the prevalence of Periodontitis Stage III & IV in adult Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University


Recruitment information / eligibility

Status Completed
Enrollment 750
Est. completion date September 15, 2019
Est. primary completion date June 15, 2019
Accepts healthy volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Patients whose age is above 15 years old.

- Patient consulting in the outpatient clinic

- Provide informed consent.

Exclusion Criteria:

- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.

- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of Dentistry , Cairo Univeristy Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of Periodontitis stage III & IV after recriutment of required sample size , through study completion an average of one year
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