Gummy SmileNCT04553952
The Distribution of Gingival Display and Possible Related Factors Resulting in Gummy Smile
An observational study of Gummy Smile, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile. Read more about this study
- Who is it for?
- Ages 20 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Measurement of gingival display
- How many people
- 501 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2019to 22 Mar 2020
- 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 20 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who applied to Baskent University Faculty of Dentistry for seeking dental treatment
Who may be able to join
- presence of teeth in upper jaw
- Age between 18-65 years
Who cannot join
- Patients who have received and/or are receiving orthodontic treatment and patients who received gummy smile treatment were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University,Department of Dentistry
Ankara
About this study
Official title: Evaluating the Distribution of Gingival Display and Possible Related Factors Resulting in Gummy Smile
This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.
Read the detailed description
this study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.Age, gender, marital status, medical history, and medication status of the patients were recorded. All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler.Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all. Presence of altered passive eruption, short lip and hypermobile upper lip were also evaluated.
- Conditions
- Gummy Smile
- Being tested
- Measurement of gingival display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of gingival displayOther
All individuals were instructed to sit on a dental chair and the measurements were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows:
Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.
| Study group | Role | What they receive |
|---|---|---|
| Gummy smile (GS(+)) | Not described Receives: Other: Measurement of gingival display | |
| Gumms smile(GS(-)) | Not described Receives: Other: Measurement of gingival display |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gingival display
All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows:
Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start9 Nov 2019
- Primary completion24 Feb 2020
- Study completion22 Mar 2020
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.
- 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
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Bilgin Çetin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553952
- Sponsor's protocol ID
- MBilgin
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Distribution of Gingival Display and Possible Related Factors Resulting in Gummy Smile
- ClinicalTrials.gov ID
- NCT04553952
- Acronym / sponsor ID
- MBilgin
- Conditions
- Gummy Smile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 9 Nov 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 18 Sep 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.
This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.
Detailed description
this study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.Age, gender, marital status, medical history, and medication status of the patients were recorded. All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler.Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all. Presence of altered passive eruption, short lip and hypermobile upper lip were also evaluated.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gummy smile (GS(+)) | – | Other: Measurement of gingival display |
| Gumms smile(GS(-)) | – | Other: Measurement of gingival display |
Who may qualify
- Ages
- 20 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who applied to Baskent University Faculty of Dentistry for seeking dental treatment
Key inclusion criteria (2 listed)
- presence of teeth in upper jaw
- Age between 18-65 years
Key exclusion criteria (1 listed)
- Patients who have received and/or are receiving orthodontic treatment and patients who received gummy smile treatment were excluded.
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 |
|---|---|---|
| Measurement of gingival displayAll individuals were instructed to sit on a dental chair and the measurements were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all. | Other | Gumms smile(GS(-)), Gummy smile (GS(+)) |
Primary outcome
Measurement of gingival display
Time frame: 1 minute
All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.
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 18 Sep 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 Gummy Smile, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 18 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 Turkey (Türkiye). 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?
Measurement of gingival display (time frame: 1 minute). 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 18 Sep 2020.