Gummy Smile and Artificial Intelligence

NCT06819137 | Active Not Recruiting

• 1 other identifier: 13.02.2024/03
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gummy Smile

Outcome Measures

Primary Outcomes (1)

• value of gummy smile visibility using artificial intelligence algorithms

  gummy smile visibility

  1 month

Study Arms (1)

High gingival line

Gingival visibility exceeding 3 mm during smiling.

Other: Gingival visibility exceeding 3 mm during smiling

Interventions

Gingival visibility exceeding 3 mm during smiling OTHER

Obtaining gummy smile photographs in accordance with the inclusion criteria specified in the study's materials and methods section.

High gingival line

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult individuals with a gummy smile who provide consent for photographic documentation

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Zeynep Turgut Çankaya

Ankara, 06510, Turkey (Türkiye)

Location

Study Officials

• Zeynep Turgut Çankaya, Phd DDS

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gazi University

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: January 31, 2025
• Primary Completion: February 28, 2025
• Study Completion: March 2, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will become available whitin 1 month and will be available one year

Locations

TU (1)