Altered Passive Eruption of TeethNCT07548398
Gummy Smile and Altered Passive Eruption Prevalence
An observational study of Altered Passive Eruption of Teeth, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This observational epidemiological study aims to assess the prevalence of gummy smile and altered passive eruption in a young adult population, with a focus on the second sextant. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Altered Passive Eruption of Teeth
- What is being tested?
- Clinical assessment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 1 Dec 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population will include individuals with and without excessive gingival display, in order to assess the prevalence of gummy smile and its association with altered passive eruption and related anatomical and aesthetic parameters. Particular attention will be given to the second sextant, which represents the area most frequently involved in gingival display. All participants will undergo a non-invasive clinical and photographic assessment aimed at evaluating gingival exposure, clinical crown dimensions, and other relevant anatomical features. In addition, patient-reported outcomes regarding aesthetic perception and psychosocial impact will be collected.
Who may be able to join
- Male and female subjects;
- Age between 18 and 50 years;
- Periodontally healthy subjects;
- Patients with no history of orthodontic treatment;
- Patients without gingival hypertrophy or hyperplasia.
Who cannot join
- Age < 18 or > 50 years;
- Patients diagnosed with Stage I-IV periodontitis;
- Patients currently undergoing orthodontic treatment;
- Patients with severe dental crowding in the second sextant;
- Patients taking medications associated with gingival hypertrophy or -hyperplasia;
- Patients unwilling to provide informed consent;
Show all 14Show fewer
- Patients with fixed or removable prostheses in the second sextant;
- Patients with a history of surgical procedures in the second sextant;
- Patients with uncontrolled diabetes or neuropsychiatric disorders;
- Patients with infectious diseases;
- Pregnant or breastfeeding women, or those with suspected pregnancy;
- Patients taking bisphosphonates;
- Oncologic patients and those undergoing head and neck radiotherapy or receiving chemotherapy;
- Patients with alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sapienza università di Roma
Roma, RM, 00161
Fabrizio Guerra, 3283150627, prof.fabrizio.guerra@gmail.com
About this study
Official title: Prevalence of Gummy Smile and Altered Passive Eruption in a Young Adult Population.
This observational epidemiological study aims to assess the prevalence of gummy smile and altered passive eruption in a young adult population, with a focus on the second sextant. Periodontal and aesthetic parameters, along with patient-reported discomfort, will be analyzed to identify potential correlations and underlying anatomical factors.
Read the detailed description
The primary aim of this study is to evaluate the prevalence of gummy smile, with particular focus on altered passive eruption, in a young adult population. Additionally, the study seeks to analyze key aesthetic and periodontal parameters in order to better understand their role in the etiology and clinical manifestation of excessive gingival display. Special attention is given to the second sextant, which is most frequently involved in gummy smile, to investigate the local distribution of these alterations and their diagnostic relevance.
Furthermore, the study aims to explore the relationship between the extent of gingival exposure and variations in periodontal parameters, while also assessing the level of aesthetic, psychological, and social discomfort perceived by affected individuals. Data analysis will also allow the identification of potential individual anatomical factors, such as the position of the mucogingival junction and clinical crown dimensions, that may be associated with altered passive eruption.
This is an observational epidemiological study designed to evaluate periodontal aesthetic parameters in patients attending their first clinical visit. The study will also assess the presence of aesthetic discomfort, investigate possible correlations, and explore the need for treatment related to second sextant conditions. Patients selected according to specific inclusion and exclusion criteria will undergo an operator-patient interview to collect anamnestic and clinical data. documentation.
- Conditions
- Altered Passive Eruption of Teeth
- Being tested
- Clinical assessment
- Keywords
- altered passive eruption, gummy smile, aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
Non-invasive clinical evaluation including measurement of aesthetic indices (PES/WES), and intraoral photographic documentation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young adults | Young adult subjects undergoing first dental examination, evaluated for periodontal and aesthetic parameters and the presence of excessive gingival display. Receives: Other: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival display during smiling
Quantitative assessment of gingival display during posed smile, measured as the vertical distance (in millimeters) between the inferior border of the upper lip and the gingival margin of the maxillary central incisors. Continuous variable (mm), measured using a calibrated periodontal probe and standardized intraoral photographs.
Measured: Baseline (single visit)
Prevalence of altered passive eruption (APE)
Assessment of the presence of altered passive eruption based on clinical crown dimensions and gingival margin position relative to anatomical landmarks. Measurement scale: Categorical variable (Presence/Absence)
Measured: Baseline
Secondary outcomes (1)
Clinical crown length of maxillary anterior teeth
Measurement of the clinical crown length (in millimeters) of maxillary anterior teeth, from the incisal edge to the gingival margin with a periodontal probe.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Altered Passive Eruption of TeethStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548398
- Sponsor's protocol ID
- 1972/2025
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tatakis DN, Silva CO. Contemporary treatment techniques for excessive gingival display caused by altered passive eruption or lip hypermobility. J Dent. 2023 Nov;138:104711. doi: 10.1016/j.jdent.2023.104711. Epub 2023 Sep 18.
PubMed 37730094
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gummy Smile and Altered Passive Eruption in a Young Adult Population.
- ClinicalTrials.gov ID
- NCT07548398
- Acronym / sponsor ID
- 1972/2025
- Conditions
- Altered Passive Eruption of Teeth
- Keywords
- altered passive eruption, gummy smile, aesthetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Apr 2026 (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 observational epidemiological study aims to assess the prevalence of gummy smile and altered passive eruption in a young adult population, with a focus on the second sextant. Periodontal and aesthetic parameters, along with patient-reported discomfort, will be analyzed to identify potential correlations and underlying anatomical factors.
Detailed description
The primary aim of this study is to evaluate the prevalence of gummy smile, with particular focus on altered passive eruption, in a young adult population. Additionally, the study seeks to analyze key aesthetic and periodontal parameters in order to better understand their role in the etiology and clinical manifestation of excessive gingival display. Special attention is given to the second sextant, which is most frequently involved in gummy smile, to investigate the local distribution of these alterations and their diagnostic relevance.
Furthermore, the study aims to explore the relationship between the extent of gingival exposure and variations in periodontal parameters, while also assessing the level of aesthetic, psychological, and social discomfort perceived by affected individuals. Data analysis will also allow the identification of potential individual anatomical factors, such as the position of the mucogingival junction and clinical crown dimensions, that may be associated with altered passive eruption.
This is an observational epidemiological study designed to evaluate periodontal aesthetic parameters in patients attending their first clinical visit. The study will also assess the presence of aesthetic discomfort, investigate possible correlations, and explore the need for treatment related to second sextant conditions. Patients selected according to specific inclusion and exclusion criteria will undergo an operator-patient interview to collect anamnestic and clinical data. documentation.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young adults | – | Other: Clinical assessmentYoung adult subjects undergoing first dental examination, evaluated for periodontal and aesthetic parameters and the presence of excessive gingival display. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population will include individuals with and without excessive gingival display, in order to assess the prevalence of gummy smile and its association with altered passive eruption and related anatomical and aesthetic parameters. Particular attention will be given to the second sextant, which represents the area most frequently involved in gingival display. All participants will undergo a non-invasive clinical and photographic assessment aimed at evaluating gingival exposure, clinical crown dimensions, and other relevant anatomical features. In addition, patient-reported outcomes regarding aesthetic perception and psychosocial impact will be collected.
Key inclusion criteria (5 listed)
- Male and female subjects;
- Age between 18 and 50 years;
- Periodontally healthy subjects;
- Patients with no history of orthodontic treatment;
- Patients without gingival hypertrophy or hyperplasia.
Key exclusion criteria (14 listed)
- Age < 18 or > 50 years;
- Patients diagnosed with Stage I-IV periodontitis;
- Patients currently undergoing orthodontic treatment;
- Patients with severe dental crowding in the second sextant;
- Patients taking medications associated with gingival hypertrophy or -hyperplasia;
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 |
|---|---|---|
| Clinical assessmentNon-invasive clinical evaluation including measurement of aesthetic indices (PES/WES), and intraoral photographic documentation. | Other | Healthy young adults |
Primary outcome
Gingival display during smiling
Time frame: Baseline (single visit)
Quantitative assessment of gingival display during posed smile, measured as the vertical distance (in millimeters) between the inferior border of the upper lip and the gingival margin of the maxillary central incisors. Continuous variable (mm), measured using a calibrated periodontal probe and standardized intraoral photographs.
Prevalence of altered passive eruption (APE)
Time frame: Baseline
Assessment of the presence of altered passive eruption based on clinical crown dimensions and gingival margin position relative to anatomical landmarks. Measurement scale: Categorical variable (Presence/Absence)
1 secondary outcome
Clinical crown length of maxillary anterior teeth
Time frame: Baseline
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 29 Apr 2026.
- Background: PubMed 37730094Tatakis DN, Silva CO. Contemporary treatment techniques for excessive gingival display caused by altered passive eruption or lip hypermobility. J Dent. 2023 Nov;138:104711. doi: 10.1016/j.jdent.2023.104711. Epub 2023 Sep 18.
- 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.
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 Altered Passive Eruption of Teeth, run by University of Roma La Sapienza at 1 site in Italy.
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 14 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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 Italy. 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?
Contact Fabrizio Guerra (3283150627, fabrizio.guerra@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival display during smiling (time frame: Baseline (single visit)). The study lists 2 primary outcomes in all. 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 NCT07548398, which also lists 1 linked publication.
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 29 Apr 2026.