Gummy SmileNCT05132010
Prevalence of Gummy Smile and Its Causes Among the Egyptian Population.
An observational study of Gummy Smile, run by Cairo University at 1 site in Egypt.
Trial summary
prevalence of gummy smile among the Egyptian population Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gummy Smile
- How many people
- 444 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2020to 10 Jul 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Egyptian population
Who may be able to join
- patients attending El kasr el Aini hospital at the department of periodontology.
- patients whose above 18 years old of both genders
- patients consulting the outpatient clinic
- provide informed consent
Who cannot join
- less than 18 years old
- patients having problems opening their mouth or undergoing inter maxillary fixation where oral examination will not be possible
- patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
- patients with gingival hyperplasia
- patients with extracted maxillary anterior teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Gummy Smile: Cross-Sectional Study on A Sample of Egyptian Patients
prevalence of gummy smile among the Egyptian population
Read the detailed description
prevalence of gummy smile among Egyptian population in patients attending the kasr el aini hospital
- Conditions
- Gummy Smile
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of gummy smile
To detect the prevalence of gummy smile among Egyptian population
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
determining associated risk factors and classifying them onto further sub analytical groups
all the causes prevalence within the sample will be calculated
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 posted23 Nov 2021
- Study start10 Dec 2020
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy SmileStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mostafa ahmed abo el soud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132010
- Sponsor's protocol ID
- prevalence of gummy smile
- Status last verified
- Sep 2024
- First submitted
- 16 Nov 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gummy Smile: Cross-Sectional Study on A Sample of Egyptian Patients
- ClinicalTrials.gov ID
- NCT05132010
- Acronym / sponsor ID
- prevalence of gummy smile
- Conditions
- Gummy Smile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 23 Nov 2021 (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.
prevalence of gummy smile among the Egyptian population
Detailed description
prevalence of gummy smile among Egyptian population in patients attending the kasr el aini hospital
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Egyptian population
Key inclusion criteria (4 listed)
- patients attending El kasr el Aini hospital at the department of periodontology.
- patients whose above 18 years old of both genders
- patients consulting the outpatient clinic
- provide informed consent
Key exclusion criteria (5 listed)
- less than 18 years old
- patients having problems opening their mouth or undergoing inter maxillary fixation where oral examination will not be possible
- patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
- patients with gingival hyperplasia
- patients with extracted maxillary anterior teeth
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 gummy smile
Time frame: through study completion, an average of 1 year
To detect the prevalence of gummy smile among Egyptian population
1 secondary outcome
determining associated risk factors and classifying them onto further sub analytical groups
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 19 Sep 2024.
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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 Gummy Smile, 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 4 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 gummy smile (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?
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 19 Sep 2024.