Periodontal DiseasesNCT04532255
Periodontal Health Knowledge Among Patients With Fixed Orthodontic Appliance
An observational study of Periodontal Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
The study is a cross-sectional survey investigating the Periodontal health knowledge among patients with fixed orthodontic appliance attending the orthodontic department and the paid section faculty of dentistry Cairo University. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- How many people
- 314 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Aug 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with fixed orthodontic appliance attending the orthodontic department and the paid section faculty of dentistry Cairo University.
Who may be able to join
- Patients whose age is 15-35 years old.
- Patients with upper and lower fixed orthodontic appliances.
- The duration of orthodontic treatment is 12 ±8 months.
- All subjects were instructed for the need to properly clean the teeth after placing the appliance.
- Provide informed consent
Who cannot join
- Individuals with chronic systemic diseases such as diabetes, endocrine and haematological pathologies.
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Pregnant women.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Patients with congenital disorders or craniofacial anomalies such as cleft lip and palate and advanced (Sever) Periodontitis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medecine-CU
Cairo
Mahmoud Elbelkemy, master, 00201091567535, mahmoud.elbelkemy@dentistry.cu.edu.eg
About this study
Official title: Periodontal Health Knowledge Among Patients With Fixed Orthodontic Appliance: A Hospital Based Cross-sectional Study
The study is a cross-sectional survey investigating the Periodontal health knowledge among patients with fixed orthodontic appliance attending the orthodontic department and the paid section faculty of dentistry Cairo University.
The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.
Read the detailed description
Dental patients will be recruited in a consecutive manner from orthodontic department 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.
- Full questionnaire will be filled, then full mouth periodontal examination and charting will be done for each patient.
- The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
- The interview questions will be prepared in English, translated into Arabic and then reverse translated by a certified translator to ensure accuracy.
- All the interviews done by the same investigator.
- Before the interview, 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.
- Conventional clinical examination will be held on a dental unit using the light of the unit, mirror and probe.
- Periodontal status will be evaluated including assessment of gingival index (GI), plaque index (PI), probing pocket depth (PPD) and number of teeth with gingival recession by using UNC 15 periodontal probe which is 15mm long probe with markings at each millimeter and color coded at 5th ,10th and 15th mm.
- The questionnaire which was applied in previous study will include the following:
- A series of questions related to demographic characteristics of the individuals; age, gender, duration of fixed orthodontic treatment, and the patient's current oral health behaviour (frequency and duration of tooth brushing, and auxiliary aids).
- Questions about periodontal knowledge of the individuals.
- Questions about awareness of patients toward the periodontal health.
- Questions related to subject's attitude toward orthodontic treatment and periodontal health.
- 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.
Periodontal health knowledge in patients receiving fixed orthodontic treatment.
will be assessed from Six questions about periodontal knowledge of the individuals and answers will be given in the form of multiple choices, with only one correct answer. These questions will be scored as 0 if the answer was in correct and as 1 if the answer was correct.
Measured: An average of 1 year through study completion.
Secondary outcomes (1)
The attitude and awareness toward orthodontic treatment and periodontal health.
will be assessed from Ten questions related to subject's awareness toward periodontal health that will be scored as 0 if the answer was "I don't know" and as 1 if the answer was "yes" or "no".
The levels of awareness will be determined according to the scores and Ten questions related to subject's attitude toward orthodontic treatment and periodontal health that will be scored as 0 if the answer was negative and as 1 if the answer was positive.
Measured: An average of 1 year through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Fekry Abbas El belkemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532255
- Sponsor's protocol ID
- PER 1-1-1
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Health Knowledge Among Patients With Fixed Orthodontic Appliance: A Hospital Based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04532255
- Acronym / sponsor ID
- PER 1-1-1
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 31 Aug 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 study is a cross-sectional survey investigating the Periodontal health knowledge among patients with fixed orthodontic appliance attending the orthodontic department and the paid section faculty of dentistry Cairo University.
The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center.
Detailed description
Dental patients will be recruited in a consecutive manner from orthodontic department 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.
- Full questionnaire will be filled, then full mouth periodontal examination and charting will be done for each patient.
- The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
- The interview questions will be prepared in English, translated into Arabic and then reverse translated by a certified translator to ensure accuracy.
- All the interviews done by the same investigator.
- Before the interview, 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.
- Conventional clinical examination will be held on a dental unit using the light of the unit, mirror and probe.
- Periodontal status will be evaluated including assessment of gingival index (GI), plaque index (PI), probing pocket depth (PPD) and number of teeth with gingival recession by using UNC 15 periodontal probe which is 15mm long probe with markings at each millimeter and color coded at 5th ,10th and 15th mm.
- The questionnaire which was applied in previous study will include the following:
- A series of questions related to demographic characteristics of the individuals; age, gender, duration of fixed orthodontic treatment, and the patient's current oral health behaviour (frequency and duration of tooth brushing, and auxiliary aids).
- Questions about periodontal knowledge of the individuals.
- Questions about awareness of patients toward the periodontal health.
- Questions related to subject's attitude toward orthodontic treatment and periodontal health.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with fixed orthodontic appliance attending the orthodontic department and the paid section faculty of dentistry Cairo University.
Key inclusion criteria (5 listed)
- Patients whose age is 15-35 years old.
- Patients with upper and lower fixed orthodontic appliances.
- The duration of orthodontic treatment is 12 ±8 months.
- All subjects were instructed for the need to properly clean the teeth after placing the appliance.
- Provide informed consent
Key exclusion criteria (5 listed)
- Individuals with chronic systemic diseases such as diabetes, endocrine and haematological pathologies.
- Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.
- Pregnant women.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Patients with congenital disorders or craniofacial anomalies such as cleft lip and palate and advanced (Sever) Periodontitis.
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
Periodontal health knowledge in patients receiving fixed orthodontic treatment.
Time frame: An average of 1 year through study completion.
will be assessed from Six questions about periodontal knowledge of the individuals and answers will be given in the form of multiple choices, with only one correct answer. These questions will be scored as 0 if the answer was in correct and as 1 if the answer was correct.
1 secondary outcome
The attitude and awareness toward orthodontic treatment and periodontal health.
Time frame: An average of 1 year through study completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- 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.
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 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 5 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: status not confirmed, as of the sponsor's last update on 1 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Elbelkemy, Master (00201091567535, mahmoud.elbelkemy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal health knowledge in patients receiving fixed orthodontic treatment. (time frame: An average of 1 year through study completion.). 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 1 Sep 2020.