Gummy SmileNCT06819137
Gummy Smile and Artificial Intelligence
An observational study of Gummy Smile, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
A smile, as a nonverbal communication tool, is based on a balanced relationship between the teeth and the surrounding hard and soft tissues. The literature highlights the need for the evaluation of smile design using artificial intelligence (AI), suggesting that AI-assisted assessments could play a crucial role in all… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Gingival visibility exceeding 3 mm during smiling
- How many people
- 650 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 2 Mar 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult individuals with a gummy smile who provide consent for photographic documentation
Who may be able to join
- Participants aged between 18 and 55 years.
- Gingival Display During Smiling:
- Presence of more than 3 mm of gingival display above the maxillary anterior teeth during smiling.
- Gummy smile severity exceeding a predefined threshold, categorized as mild, moderate, or severe.
- Oral and Periodontal Health:
- Periodontally healthy individuals or those with minimal gingival inflammation. Anterior teeth free of caries or extensive restorations that may affect esthetic evaluation.
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- Participants with Class I occlusion or mild malocclusion.
- Presence of etiological factors contributing to gummy smile, such as:
- Vertical maxillary excess (VME) Hyperactive upper lip Altered passive eruption
- History of Orthodontic or Surgical Treatment:
- No history of previous gummy smile correction treatments. No orthodontic treatment or surgical intervention within the last 6-12 months.
- Systemic Health and Medication Use:
- Absence of systemic diseases or medication use that could influence gingival display.
- Image Quality Requirements:
- High-resolution and standardized photographs or video recordings. Images captured under consistent lighting conditions and fixed angles to ensure accurate evaluation of gingival display.
Who cannot join
- Periodontal and Dental Conditions:
- Presence of severe periodontal disease (e.g., periodontitis, gingival hyperplasia).
- Extensive carious lesions, large restorations, or prosthetic crowns on anterior teeth.
- History of traumatic dental injuries affecting the maxillary anterior region.
- Occlusal and Skeletal Anomalies:
- Severe malocclusion (e.g., Class II or III, open bite, crossbite). Jaw deformities requiring orthognathic surgery.
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- History of Previous Treatment for Gummy Smile:
- Prior orthodontic treatment, periodontal surgery, or botulinum toxin injections for gummy smile correction.
- History of orthognathic or maxillofacial surgery altering gingival display.
- Systemic Health Conditions and Medication Use:
- Presence of systemic diseases that could affect gingival tissue or facial muscle function (e.g., diabetes, neuromuscular disorders).
- Use of medications known to induce gingival overgrowth, such as:
- Calcium channel blockers Phenytoin Cyclosporine
- Inadequate Image Quality for AI Analysis:
- Low-resolution, blurred, or poorly standardized photographs. Inconsistent lighting conditions or improper facial positioning in images.
- Pregnancy and Hormonal Influence:
- Pregnant or postpartum individuals, as hormonal changes may temporarily influence gingival display.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Gummy Smile With Artificial ıntelligence
A smile, as a nonverbal communication tool, is based on a balanced relationship between the teeth and the surrounding hard and soft tissues. The literature highlights the need for the evaluation of smile design using artificial intelligence (AI), suggesting that AI-assisted assessments could play a crucial role in all relevant stages of clinical parameters associated with gingival smile analysis. A gummy smile (GS) is defined as the excessive display of gingival tissue exceeding 3 mm during smiling.
The hypothesis of this study is based on the assumption that clinical data obtained for the analysis and diagnosis of gingival visibility can be accurately and reliably evaluated using AI-supported algorithms. To date, no study has been found in the literature that diagnoses GS using AI, predicts its etiological factors, and assesses its implications for treatment planning.
Read the detailed description
Detailed Description
Among the causes of gummy smile (GS) are:
Excessive vertical development of the anterior maxilla Hyperactivity of the perioral muscles, leading to excessive lip elevation during smiling Short clinical crown length, which increases susceptibility to GS Altered passive eruption, gingival inflammation, and gingival hyperplasia contribute to a reduced clinical crown length. Cases where the vertical dimension of the teeth is shorter than the horizontal dimension suggest that passive eruption is a contributing factor to GS.
The extent of GS is not homogenous across all teeth involved in the smile and often results from multiple etiological factors. When gingival display is 3 mm, it is attributed solely to excessive gingival tissue. If an additional 2.2 mm of gingival display is present (3 mm + 2.2 mm), vertical maxillary excess (VME) is considered a contributing factor. When an additional 2.8 mm of gingival display is observed (3 mm + 2.2 mm + 2.8 mm), a hypermobile (HM) lip is implicated.
For instance:
A 3 mm GS over the maxillary left central incisor may be due to HM lip alone
A ≥8 mm GS over the maxillary left second premolar may result from a combination of:
HM lip (2.8 mm) Excessive gingival tissue (3 mm) VME (2.2 mm) This highlights the importance of measuring GS at each tooth level for accurate diagnosis and personalized treatment planning.
Assessing asymmetric GS requires individual measurements for each tooth, which can increase error likelihood and patient chair time. Given the significance of scientific research in identifying personalized intervention strategies for esthetic smile design, artificial intelligence (AI) could help transform the subjective nature of aesthetic perception into an individualized, scientific framework by adhering to specific reference parameters. The use of precise and valid measurements in GS evaluation can facilitate:
Diagnosis Etiological assessment Treatment planning By establishing a comprehensive dataset, the contributions of various etiologies can be analyzed by comparing measured variables with ideal reference values. A meticulous analysis of etiopathogenetic factors and the severity of the condition can be achieved through such an approach. Previous research indicates a need for more studies validating the accuracy and sensitivity of GS diagnosis and its etiological assessment.
AI-Based Analysis and Dataset Formation To date, no study has been found in the literature evaluating gingival display using AI. Unlike studies that use test datasets or publicly available open-access datasets for accuracy scoring, the data obtained in this research are exclusively derived from a training dataset.
To optimize the validation strategy of the AI model, selected clinical metrics were measured separately for each tooth involved in GS. Labeling was performed using a licensed web-based annotation platform that allows for multiple annotation options.
This study will include patients with a high smile line, selected from those who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University. The labeling of patient photographs will be performed by two researchers:
A periodontologist A senior expert in artificial intelligence (AI) \& software development Photographs of patients with gummy smile (GS) will be used to create training, validation, and test datasets.
Methodology for Dataset Formation
The simple random sampling method was used, with:
Confidence level: 0.95 Prevalence: 0.1 Margin of error: 0.05
The formation of these datasets will follow the steps outlined below:
A literature review was conducted to identify standardization methods for gingival visibility measurements. However, no standardized ruler system was found that allows for simultaneous calibration and measurement of gingival display across multiple teeth. Consequently, the need to develop a custom-designed ruler system specifically for this research emerged.
AI Model Training and Data Processing
Gingival display will be determined using a hybrid model. The training process will include:
Pixel Accuracy (PA) Mean Intersection over Union (mIoU) metrics
The dataset will be divided into:
Training set Validation set Testing set
Image preprocessing will include:
Resizing Normalization Transformation into tensors
- Conditions
- Gummy Smile
- Being tested
- Gingival visibility exceeding 3 mm during smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival visibility exceeding 3 mm during smilingOther
Obtaining gummy smile photographs in accordance with the inclusion criteria specified in the study's materials and methods section.
| Study group | Role | What they receive |
|---|---|---|
| High gingival line | Gingival visibility exceeding 3 mm during smiling. Receives: Other: Gingival visibility exceeding 3 mm during smiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
value of gummy smile visibility using artificial intelligence algorithms
gummy smile visibility
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start31 Jan 2025
- Primary completion28 Feb 2025 (estimated)
- Study completion2 Mar 2025 (estimated)
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Turgut Çankaya, Gazi University
- Investigators
- Zeynep Turgut Çankaya, Phd DDS, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819137
- Sponsor's protocol ID
- 13.02.2024/03
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gummy Smile With Artificial ıntelligence
- ClinicalTrials.gov ID
- NCT06819137
- Acronym / sponsor ID
- 13.02.2024/03
- Conditions
- Gummy Smile
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
A smile, as a nonverbal communication tool, is based on a balanced relationship between the teeth and the surrounding hard and soft tissues. The literature highlights the need for the evaluation of smile design using artificial intelligence (AI), suggesting that AI-assisted assessments could play a crucial role in all relevant stages of clinical parameters associated with gingival smile analysis. A gummy smile (GS) is defined as the excessive display of gingival tissue exceeding 3 mm during smiling.
The hypothesis of this study is based on the assumption that clinical data obtained for the analysis and diagnosis of gingival visibility can be accurately and reliably evaluated using AI-supported algorithms. To date, no study has been found in the literature that diagnoses GS using AI, predicts its etiological factors, and assesses its implications for treatment planning.
Detailed description
Detailed Description
Among the causes of gummy smile (GS) are:
Excessive vertical development of the anterior maxilla Hyperactivity of the perioral muscles, leading to excessive lip elevation during smiling Short clinical crown length, which increases susceptibility to GS Altered passive eruption, gingival inflammation, and gingival hyperplasia contribute to a reduced clinical crown length. Cases where the vertical dimension of the teeth is shorter than the horizontal dimension suggest that passive eruption is a contributing factor to GS.
The extent of GS is not homogenous across all teeth involved in the smile and often results from multiple etiological factors. When gingival display is 3 mm, it is attributed solely to excessive gingival tissue. If an additional 2.2 mm of gingival display is present (3 mm + 2.2 mm), vertical maxillary excess (VME) is considered a contributing factor. When an additional 2.8 mm of gingival display is observed (3 mm + 2.2 mm + 2.8 mm), a hypermobile (HM) lip is implicated.
For instance:
A 3 mm GS over the maxillary left central incisor may be due to HM lip alone
A ≥8 mm GS over the maxillary left second premolar may result from a combination of:
HM lip (2.8 mm) Excessive gingival tissue (3 mm) VME (2.2 mm) This highlights the importance of measuring GS at each tooth level for accurate diagnosis and personalized treatment planning.
Assessing asymmetric GS requires individual measurements for each tooth, which can increase error likelihood and patient chair time. Given the significance of scientific research in identifying personalized intervention strategies for esthetic smile design, artificial intelligence (AI) could help transform the subjective nature of aesthetic perception into an individualized, scientific framework by adhering to specific reference parameters. The use of precise and valid measurements in GS evaluation can facilitate:
Diagnosis Etiological assessment Treatment planning By establishing a comprehensive dataset, the contributions of various etiologies can be analyzed by comparing measured variables with ideal reference values. A meticulous analysis of etiopathogenetic factors and the severity of the condition can be achieved through such an approach. Previous research indicates a need for more studies validating the accuracy and sensitivity of GS diagnosis and its etiological assessment.
AI-Based Analysis and Dataset Formation To date, no study has been found in the literature evaluating gingival display using AI. Unlike studies that use test datasets or publicly available open-access datasets for accuracy scoring, the data obtained in this research are exclusively derived from a training dataset.
To optimize the validation strategy of the AI model, selected clinical metrics were measured separately for each tooth involved in GS. Labeling was performed using a licensed web-based annotation platform that allows for multiple annotation options.
This study will include patients with a high smile line, selected from those who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University. The labeling of patient photographs will be performed by two researchers:
A periodontologist A senior expert in artificial intelligence (AI) \& software development Photographs of patients with gummy smile (GS) will be used to create training, validation, and test datasets.
Methodology for Dataset Formation
The simple random sampling method was used, with:
Confidence level: 0.95 Prevalence: 0.1 Margin of error: 0.05
The formation of these datasets will follow the steps outlined below:
A literature review was conducted to identify standardization methods for gingival visibility measurements. However, no standardized ruler system was found that allows for simultaneous calibration and measurement of gingival display across multiple teeth. Consequently, the need to develop a custom-designed ruler system specifically for this research emerged.
AI Model Training and Data Processing
Gingival display will be determined using a hybrid model. The training process will include:
Pixel Accuracy (PA) Mean Intersection over Union (mIoU) metrics
The dataset will be divided into:
Training set Validation set Testing set
Image preprocessing will include:
Resizing Normalization Transformation into tensors
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High gingival line | – | Other: Gingival visibility exceeding 3 mm during smilingGingival visibility exceeding 3 mm during smiling. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult individuals with a gummy smile who provide consent for photographic documentation
Key inclusion criteria (15 listed)
- Participants aged between 18 and 55 years.
- Presence of more than 3 mm of gingival display above the maxillary anterior teeth during smiling.
- Gummy smile severity exceeding a predefined threshold, categorized as mild, moderate, or severe.
- Periodontally healthy individuals or those with minimal gingival inflammation. Anterior teeth free of caries or extensive restorations that may affect esthetic evaluation.
- Participants with Class I occlusion or mild malocclusion.
Key exclusion criteria (17 listed)
- Presence of severe periodontal disease (e.g., periodontitis, gingival hyperplasia).
- Extensive carious lesions, large restorations, or prosthetic crowns on anterior teeth.
- History of traumatic dental injuries affecting the maxillary anterior region.
- Severe malocclusion (e.g., Class II or III, open bite, crossbite). Jaw deformities requiring orthognathic surgery.
- Prior orthodontic treatment, periodontal surgery, or botulinum toxin injections for gummy smile correction.
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 |
|---|---|---|
| Gingival visibility exceeding 3 mm during smilingObtaining gummy smile photographs in accordance with the inclusion criteria specified in the study's materials and methods section. | Other | High gingival line |
Primary outcome
value of gummy smile visibility using artificial intelligence algorithms
Time frame: 1 month
gummy smile visibility
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. Upon request
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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.
Zeynep Turgut Çankaya, Phd DDS study director
Gazi 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 Gummy Smile, run by Gazi 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 15 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
value of gummy smile visibility using artificial intelligence algorithms (time frame: 1 month). 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 13 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.