Chronic PeriodontitisNCT04047212
The Link Between Periodontitis, Smoking and Oral Cancer
An observational study of Chronic Periodontitis and Oral Cancer, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Periodontitis, Oral Cancer
- What is being tested?
- biopsy for oral cancer and periodontal examination
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2021to 30 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult individuals
Who may be able to join
- Patients 18 years or older.
Who cannot join
- Patients with any systemic diseases.
- Pregnant females.
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Patients having oral cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, 11562
Ayat A Gamal-AbdelNaser, 01001874257, ayat.gamal@dentistry.cu.edu.eg
About this study
Official title: 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.
- Conditions
- Chronic Periodontitis, Oral Cancer
- Being tested
- biopsy for oral cancer, periodontal examination
- Medical subject headings
- Chronic Periodontitis, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy for oral cancerDiagnostic test
surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions
periodontal examinationDiagnostic test
Periodontal clinical examination to all by periodontal charting
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Not described Receives: Diagnostic Test: biopsy for oral cancer; Diagnostic Test: periodontal examination | |
| non-Smokers | Not described Receives: Diagnostic Test: biopsy for oral cancer; Diagnostic Test: periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontitis
arising of periodontitis or increase in the grade of an already existing case of periodontitis
Measured: the 10 years of the study
Secondary outcomes (1)
Oral cancer
Arising of a lesion of oral cancer or a premalignant lesion
Measured: the 10 years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start12 Aug 2021 (estimated)
- Primary completion12 Oct 2031 (estimated)
- Study completion30 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal-AbdelNaser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047212
- Sponsor's protocol ID
- P12
- Status last verified
- Jun 2021
- First submitted
- 3 Aug 2019
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Link Between Periodontitis, Smoking and Oral Cancer: Cohort Study
- ClinicalTrials.gov ID
- NCT04047212
- Acronym / sponsor ID
- P12
- Conditions
- Chronic Periodontitis, Oral Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (estimated)
- Primary completion
- 12 Oct 2031 (estimated)
- Study completion
- 30 Jan 2032 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Diagnostic Test: biopsy for oral cancer, Diagnostic Test: periodontal examination |
| non-Smokers | – | Diagnostic Test: biopsy for oral cancer, Diagnostic Test: periodontal examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals
Key inclusion criteria (1 listed)
- Patients 18 years or older.
Key exclusion criteria (5 listed)
- Patients with any systemic diseases.
- Pregnant females.
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Patients having oral cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy for oral cancersurgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions | Diagnostic test | Smokers, non-Smokers |
| periodontal examinationPeriodontal clinical examination to all by periodontal charting | Diagnostic test | Smokers, non-Smokers |
Primary outcome
Periodontitis
Time frame: the 10 years of the study
arising of periodontitis or increase in the grade of an already existing case of periodontitis
1 secondary outcome
Oral cancer
Time frame: the 10 years of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Oral Cancer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayat Gamal-AbdelNaser (01001874257, ayat.gamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontitis (time frame: the 10 years of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.