The Link Between Periodontitis, Smoking and Oral Cancer

June 13, 2021 updated by: Ayat Gamal-AbdelNaser, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult individuals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smokers
Diagnostic test: biopsy for oral cancer
surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions
Diagnostic test: periodontal examination
Periodontal clinical examination to all by periodontal charting
non-Smokers
Diagnostic test: biopsy for oral cancer
surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions
Diagnostic test: periodontal examination
Periodontal clinical examination to all by periodontal charting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontitis
Time Frame: the 10 years of the study
arising of periodontitis or increase in the grade of an already existing case of periodontitis
the 10 years of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral cancer
Time Frame: the 10 years of the study
Arising of a lesion of oral cancer or a premalignant lesion
the 10 years of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 12, 2021

Primary Completion (Anticipated)

October 12, 2031

Study Completion (Anticipated)

January 30, 2032

Study Registration Dates

First Submitted

August 3, 2019

First Submitted That Met QC Criteria

August 3, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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