- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548398
Gummy Smile and Altered Passive Eruption Prevalence
Prevalence of Gummy Smile and Altered Passive Eruption in a Young Adult Population.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fabrizio Guerra
- Phone Number: 3283150627
- Email: fabrizio.guerra@uniroma1.it
Study Locations
-
-
RM
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Roma, RM, Italy, 00161
- Recruiting
- Sapienza università di Roma
-
Contact:
- Fabrizio Guerra
- Phone Number: 3283150627
- Email: prof.fabrizio.guerra@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy young adults
Young adult subjects undergoing first dental examination, evaluated for periodontal and aesthetic parameters and the presence of excessive gingival display.
|
Non-invasive clinical evaluation including measurement of aesthetic indices (PES/WES), and intraoral photographic documentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (single visit)
|
|
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)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical crown length of maxillary anterior teeth
Time Frame: Baseline
|
Measurement of the clinical crown length (in millimeters) of maxillary anterior teeth, from the incisal edge to the gingival margin with a periodontal probe.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1972/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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