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NCT04047212 Clinical Trial

The Link Between Periodontitis, Smoking and Oral Cancer

Chronic Periodontitis Clinical Trial

Official title:
Analysis of the Link Between Periodontitis, Smoking and Oral Cancer: Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04047212
Other study ID # P12
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 12, 2021
Est. completion date January 30, 2032

Study information
Verified date June 2021
Source Cairo University
Contact Ayat Gamal-AbdelNaser
Phone 01001874257
Email ayat.gamal@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly. Changes in the oral mucosa arise by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm. Therefore, this research aims to identify the risk of smoking to both periodontitis and oral cancer, and the risk of periodontitis to oral cancer.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date January 30, 2032
Est. primary completion date October 12, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients 18 years or older. Exclusion Criteria: - Patients with any systemic diseases. - Pregnant females. - Handicapped and mentally retarded patients. - Patients undergoing radiotherapy. - Patients having oral cancer

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• biopsy for oral cancer
surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions
• periodontal examination
Periodontal clinical examination to all by periodontal charting

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Periodontitis arising of periodontitis or increase in the grade of an already existing case of periodontitis the 10 years of the study
Secondary Oral cancer Arising of a lesion of oral cancer or a premalignant lesion the 10 years of the study
See also
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Completed NCT02516111 - Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment Phase 2/Phase 3
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Completed NCT03039244 - Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers N/A
Completed NCT02898675 - Advantages of Autologous Platelet-Rich Fibrin Membrane on Growth Factor Levels and Periodontal Healing N/A
Completed NCT02518152 - Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis Phase 2/Phase 3
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