Periodontal DiseasesNCT04478864
Knowledge, Practice and State of Periodontal Health
An observational study of Periodontal Diseases, run by Noha Ayman Ghallab at 1 site in Egypt.
Trial summary
The main objective of the study is to assess the knowledge and practice of periodontal health, which will be done using a well constructed and validated questionnaire. Then periodontal health status of all participants will be assessed via clinical examination of certain teeth. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- How many people
- 511 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Sep 2020to 30 Nov 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- 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.
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: Assessment of Knowledge, Practice and State of Periodontal Health Among Egyptian Patients Attending Diagnostic Center at Faculty of Dentistry, Cairo University. A Cross-sectional Study
The main objective of the study is to assess the knowledge and practice of periodontal health, which will be done using a well constructed and validated questionnaire. Then periodontal health status of all participants will be assessed via clinical examination of certain teeth.
Read the detailed description
The primary outcome of the study is the knowledge of periodontal health.It will be assessed by 10 questions focusing on the basic knowledge of gingival appearance, causes and consequence of periodontal disease, impact of systemic disease on the progression of periodontal conditions, and prevention. Then, periodontal practice will be addressed via several questions that evaluate the self-care practices of tooth brushing, flossing, mouth rinsing in recent one year, scaling in recent five years, and how to alleviate gingival bleeding if there is.
Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The dentition will be divided into sextants and the highest code number corresponding to the worst periodontal condition around each of the 10 indexed teeth being recorded.
- Conditions
- Periodontal Diseases
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of periodontal health
will be assessed from the 10 questions in the questionnaire and be presented as frequencies and percentages.
Measured: "through study completion, an average of 1 year"
Secondary outcomes (2)
Periodontal health practice
Five questions regarding practice will be analyzed and presented as frequencies and percentages
Measured: "through study completion, an average of 1 year"
State of periodontal health
will be determined by measuring the community periodontal index of treatment needs (CPITN) and modified community periodontal index (CPI) that measures the clinical attachment level (CAL) scores, both giving a score of zero to the best periodontal condition and a score of 4 to the worst one
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start27 Sep 2020
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Ayman Ghallab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha A Ghallab, MD, Study director, Professor of Oral Medicine and Periodontology, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478864
- Sponsor's protocol ID
- Esraa2020
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Periodontol. 2018 Jun;89 Suppl 1:S17-S27. doi: 10.1002/JPER.17-0095.
PubMed 29926958Gronbeck Linden I, Hagglin C, Gahnberg L, Andersson P. Factors Affecting Older Persons' Ability to Manage Oral Hygiene: A Qualitative Study. JDR Clin Trans Res. 2017 Jul;2(3):223-232. doi: 10.1177/2380084417709267. Epub 2017 May 15.
PubMed 30938636Holtzman JS, Atchison KA, Macek MD, Markovic D. Oral Health Literacy and Measures of Periodontal Disease. J Periodontol. 2017 Jan;88(1):78-88. doi: 10.1902/jop.2016.160203. Epub 2016 Aug 13.
PubMed 27523517
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Knowledge, Practice and State of Periodontal Health Among Egyptian Patients Attending Diagnostic Center at Faculty of Dentistry, Cairo University. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04478864
- Acronym / sponsor ID
- Esraa2020
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Noha Ayman GhallabUniversity, hospital or other
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Jul 2020 (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 main objective of the study is to assess the knowledge and practice of periodontal health, which will be done using a well constructed and validated questionnaire. Then periodontal health status of all participants will be assessed via clinical examination of certain teeth.
Detailed description
The primary outcome of the study is the knowledge of periodontal health.It will be assessed by 10 questions focusing on the basic knowledge of gingival appearance, causes and consequence of periodontal disease, impact of systemic disease on the progression of periodontal conditions, and prevention. Then, periodontal practice will be addressed via several questions that evaluate the self-care practices of tooth brushing, flossing, mouth rinsing in recent one year, scaling in recent five years, and how to alleviate gingival bleeding if there is.
Periodontal examination using the community periodontal index (CPI) will be done for all of the participants to assess the status of periodontal condition. The dentition will be divided into sextants and the highest code number corresponding to the worst periodontal condition around each of the 10 indexed teeth being recorded.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- 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.
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
Knowledge of periodontal health
Time frame: "through study completion, an average of 1 year"
will be assessed from the 10 questions in the questionnaire and be presented as frequencies and percentages.
2 secondary outcomes
Periodontal health practice
Time frame: "through study completion, an average of 1 year"
State of periodontal health
Time frame: "through study completion, an average of 1 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 11 Mar 2022.
- Background: PubMed 29926958Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Periodontol. 2018 Jun;89 Suppl 1:S17-S27. doi: 10.1002/JPER.17-0095.
- Background: PubMed 30938636Gronbeck Linden I, Hagglin C, Gahnberg L, Andersson P. Factors Affecting Older Persons' Ability to Manage Oral Hygiene: A Qualitative Study. JDR Clin Trans Res. 2017 Jul;2(3):223-232. doi: 10.1177/2380084417709267. Epub 2017 May 15.
- Background: PubMed 27523517Holtzman JS, Atchison KA, Macek MD, Markovic D. Oral Health Literacy and Measures of Periodontal Disease. J Periodontol. 2017 Jan;88(1):78-88. doi: 10.1902/jop.2016.160203. Epub 2016 Aug 13.
- Individual participant dataSharing planned: No
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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.
Noha A Ghallab, MD study director
Professor of Oral Medicine and Periodontology, Cairo University
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 Periodontal Diseases, run by Noha Ayman Ghallab 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 11 Mar 2022. 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?
Knowledge of periodontal health (time frame: "through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478864, which also lists 3 linked publications.
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 11 Mar 2022.