The Link Between Periodontitis, Smoking and Oral Cancer

NCT04047212 | Not Yet Recruiting

• 1 other identifier: P12
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Periodontitis; Oral Cancer

Outcome Measures

Primary Outcomes (1)

• Periodontitis

  arising of periodontitis or increase in the grade of an already existing case of periodontitis

  the 10 years of the study

Secondary Outcomes (1)

• Oral cancer

  the 10 years of the study

Study Arms (2)

Smokers

Diagnostic Test: biopsy for oral cancer; Diagnostic Test: periodontal examination

non-Smokers

Diagnostic Test: biopsy for oral cancer; Diagnostic Test: periodontal examination

Interventions

biopsy for oral cancer DIAGNOSTIC_TEST

surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions

Smokers; non-Smokers

periodontal examination DIAGNOSTIC_TEST

Periodontal clinical examination to all by periodontal charting

Smokers; non-Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult individuals

You may qualify if:

• Patients 18 years or older.

You may not qualify if:

• Patients with any systemic diseases.
• Pregnant females.
• Handicapped and mentally retarded patients.
• Patients undergoing radiotherapy.
• Patients having oral cancer

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsy of cases having oral lesions

MeSH Terms

Conditions

Chronic Periodontitis; Mouth Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ayat Gamal-AbdelNaser

CONTACT

01001874257; ayat.gamal@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 3, 2019
• First Posted: August 6, 2019
• Study Start: August 12, 2021
• Primary Completion (Estimated): October 12, 2031
• Study Completion (Estimated): January 30, 2032
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)