NCT07548398

Brief 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. Periodontal and aesthetic parameters, along with patient-reported discomfort, will be analyzed to identify potential correlations and underlying anatomical factors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

April 16, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

altered passive eruptiongummy smileaesthetic

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    Baseline

Secondary Outcomes (1)

  • Clinical crown length of maxillary anterior teeth

    Baseline

Study Arms (1)

Healthy young adults

Young adult subjects undergoing first dental examination, evaluated for periodontal and aesthetic parameters and the presence of excessive gingival display.

Other: Clinical assessment

Interventions

Non-invasive clinical evaluation including measurement of aesthetic indices (PES/WES), and intraoral photographic documentation.

Healthy young adults

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza università di Roma

Roma, RM, 00161, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37730094BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, pHd

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations