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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Periodontitis

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