NCT06554379

Brief Summary

Anamnesis was taken from 108 patients aged 18-33 who applied to the clinic and met the inclusion criteria. Photographs of the patients' smiles were taken without any measurement. Plaque , gingival index , bleeding on probing, pocket depth measurements, clinical attachment, and gingival recession levels were measured, respectively. Patients were divided into two groups: peri-implant health and gingivitis. Gingival thickness and keratinized gingival width were also measured. In addition, the smile aesthetic index, style, type, and stage were also determined using the smile classification system. Gingival visibility was measured in mm from the photographs taken.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

August 11, 2024

Last Update Submit

February 2, 2025

Conditions

SmilingGingival Diseases

Keywords

gingivitisperiodontal healthsmile

Outcome Measures

Primary Outcomes (6)

  • Keratinized gingival thickness

    Keratinized gingival thickness refers to the vertical measurement of the gingival tissue that extends from the free gingival margin to the mucogingival junction, characterized by a keratinized epithelial layer which provides enhanced protection and stability to the underlying periodontal structures.

    Baseline

  • Keratinized gingival width

    Keratinized gingival width refers to the horizontal dimension of the gingival tissue that is keratinized, measured from the free gingival margin to the mucogingival junction.

    Baseline

  • Gingival display

    The gingival displays were measured by measuring the distances from the zenith points to the vermilion border

    Baseline

  • Smile esthetic index

    . The aforementioned factors were assigned a number (0 or 1) depending on their presence or absence, and the total of the assigned numbers indicates the subject's SEI (which ranges from 0 for very poor to 10 for very good)

    Baseline

  • Smile clasificatain system

    Smile style (Commissura smile, sharp smile, and complex smile), stage (Stage I, Stage II, Stage III, and Stage IV), and type (Type 1, Type 2, Type 3, and Type 4) were analyzed with the smile classification system

    Baseline

  • Gingival phenotype

    The visible end of the periodontal probe in the sulcus represents a thin gingival phenotype, while the invisible end corresponds to a thick gingival phenotype

    Baseline

Secondary Outcomes (6)

  • Plaque index

    Baseline

  • Gingival index

    Baseline

  • Bleeding on probing

    Baseline

  • Periodontal pocket depth

    Baseline

  • Clinical attachment level

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Periodontal health

It includes gingival healthy individuals without any periodontal disease.

Other: Periodontal health and gingivitis

Gingivitis

It includes individuals with gingivitis.

Other: Periodontal health and gingivitis

Interventions

Periodontal health and gingivitisOTHER

The presence or absence of periodontal disease in the gingiva was determined.

GingivitisPeriodontal health

Eligibility Criteria

Age18 Years - 33 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

108 systemically healthy individuals between 13 and 33 years of age

You may qualify if:

  • No systemic disease

You may not qualify if:

  • Active smoking,
  • Ongoing or past orthodontic treatment,
  • Pregnancy,
  • Nursing,
  • Individuals who have drug-induced gingival hyperplasia, hereditary gingival fibromatosis, permanent or removable prostheses in the upper front area, or missing teeth in the front region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University

Bolu, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SmilingGingival DiseasesGingivitis

Condition Hierarchy (Ancestors)

Facial ExpressionNonverbal CommunicationCommunicationBehaviorPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 15, 2024

Study Start

May 15, 2023

Primary Completion

May 15, 2023

Study Completion

June 25, 2023

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations

TU(1)