PeriodontitisNCT03779763
Prevalence Of Periodontitis Stage III & IV
An observational study of Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III \& IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Periodontitis
- How many people
- 750 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2019to 15 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: * Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University. * Medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient. * Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. * Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal. * The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions. * The Questionnaire will include a section for demographic information of age, sex, social and educational levels of the patient. It will also include questions about medical condition, habits of trauma, smoking and its frequency.
Who may be able to join
- Patients whose age is above 15 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Who cannot join
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence Of Periodontitis Stage III &IV: A Hospital-Based Cross-Sectional Study On A Sample Of Adult Egyptian Dental Patients
The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III \& IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University
Read the detailed description
Since the 1999 workshop, substantial new information has emergedfrom population studies, basic science investigations, and evidencefrom prospective studies evaluating environmental and systemic riskfactors. The analysis of this evidence has prompted the 2017 workshopto develop a new classification framework for periodontitis
In the last 30 years, the classification of periodontitis has been repeatedly upgraded in an attempt to align it with emerging scientific evidence. The workshop agreed that, consistent with current knowledge on pathophysiology, three forms of periodontitis can be identified: necrotizing periodontitis, periodontitis as a manifestation of systemic disease and the forms of the disease previously known as "chronic" or "aggressive", now grouped under a single category, "periodontitis".In revising the classification, the workshop agreed on a classification framework for periodontitis further characterized based on a multidimensional staging and grading system that could be adapted over time as new evidence emerges
Staging is largely dependent upon the severity of disease at presentationas well as on the complexity of disease management.While,grading provides supplemental information about biological features of the disease, including a history based analysis of the rate of disease progression, assessment of the risk for further progression, anticipated poor outcomes of treatment, and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient
Staging involves four categories (stages 1 through 4) and is determined after considering several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects, furcation involvement,tooth mobility and tooth loss due to periodontitis.
Stage III \& IV are characterized by interdental clinical attatchment loss > 5mm and radiographic bone loss extending to the middle or apical third of the root. In stage III, four teeth or less are lost while in stage IV, five teeth or more are lost due to periodontitis. In addition to stage II complexity, Stage III is characterized by probing depth greater than or equal 6 mm, vertical bone loss greater than or equal 3mm, furcation involvement class II or III and moderate ridge defect. In addition to stage III complexity, stage IV is characterized by severe ridge defect , bite collapse, drifting and flaring.
The study aims at determining the prevalence of Periodontitis Stage III \& IV in adult Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University
- Conditions
- Periodontitis
- Medical subject headings
- Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Periodontitis stage III & IV
Measured: after recriutment of required sample size , through study completion an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Jun 2019
- Primary completion15 Jun 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Khaled Gamil Moussa Megahed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779763
- Sponsor's protocol ID
- 21252461
- Status last verified
- Jul 2019
- First submitted
- 15 Dec 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Periodontitis Stage III &IV: A Hospital-Based Cross-Sectional Study On A Sample Of Adult Egyptian Dental Patients
- ClinicalTrials.gov ID
- NCT03779763
- Acronym / sponsor ID
- 21252461
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 19 Dec 2018 (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.
The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III \& IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University
Detailed description
Since the 1999 workshop, substantial new information has emergedfrom population studies, basic science investigations, and evidencefrom prospective studies evaluating environmental and systemic riskfactors. The analysis of this evidence has prompted the 2017 workshopto develop a new classification framework for periodontitis
In the last 30 years, the classification of periodontitis has been repeatedly upgraded in an attempt to align it with emerging scientific evidence. The workshop agreed that, consistent with current knowledge on pathophysiology, three forms of periodontitis can be identified: necrotizing periodontitis, periodontitis as a manifestation of systemic disease and the forms of the disease previously known as "chronic" or "aggressive", now grouped under a single category, "periodontitis".In revising the classification, the workshop agreed on a classification framework for periodontitis further characterized based on a multidimensional staging and grading system that could be adapted over time as new evidence emerges
Staging is largely dependent upon the severity of disease at presentationas well as on the complexity of disease management.While,grading provides supplemental information about biological features of the disease, including a history based analysis of the rate of disease progression, assessment of the risk for further progression, anticipated poor outcomes of treatment, and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient
Staging involves four categories (stages 1 through 4) and is determined after considering several variables including clinical attachment loss, amount and percentage of bone loss, probing depth, presence and extent of angular bony defects, furcation involvement,tooth mobility and tooth loss due to periodontitis.
Stage III \& IV are characterized by interdental clinical attatchment loss > 5mm and radiographic bone loss extending to the middle or apical third of the root. In stage III, four teeth or less are lost while in stage IV, five teeth or more are lost due to periodontitis. In addition to stage II complexity, Stage III is characterized by probing depth greater than or equal 6 mm, vertical bone loss greater than or equal 3mm, furcation involvement class II or III and moderate ridge defect. In addition to stage III complexity, stage IV is characterized by severe ridge defect , bite collapse, drifting and flaring.
The study aims at determining the prevalence of Periodontitis Stage III \& IV in adult Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University. * Medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient. * Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received. * Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal. * The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions. * The Questionnaire will include a section for demographic information of age, sex, social and educational levels of the patient. It will also include questions about medical condition, habits of trauma, smoking and its frequency.
Key inclusion criteria (3 listed)
- Patients whose age is above 15 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Key exclusion criteria (2 listed)
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of Periodontitis stage III & IV
Time frame: after recriutment of required sample size , through study completion an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Periodontitis stage III & IV (time frame: after recriutment of required sample size , through study completion an average of one year). 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 15 Jul 2020.