- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554379
The Effect of Periodontal Health on Smile (EPHS)
February 2, 2025 updated by: Tuğba ŞAHİN, Abant Izzet Baysal University
Investigation of the Effect of Periodontal Health on Smile Parameters: a Cross-Sectional
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bolu, Turkey, 14030
- Bolu Abant İzzet Baysal Üniversity
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
108 systemically healthy individuals between 13 and 33 years of age
Description
Inclusion Criteria:
- No systemic disease
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Periodontal health
It includes gingival healthy individuals without any periodontal disease.
|
The presence or absence of periodontal disease in the gingiva was determined.
|
|
Gingivitis
It includes individuals with gingivitis.
|
The presence or absence of periodontal disease in the gingiva was determined.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Keratinized gingival thickness
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
The gingival displays were measured by measuring the distances from the zenith points to the vermilion border
|
Baseline
|
|
Smile esthetic index
Time Frame: Baseline
|
. 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
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding on probing
Time Frame: Baseline
|
Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.
|
Baseline
|
|
Plaque index
Time Frame: Baseline
|
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
|
Baseline
|
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Clinical attachment level
Time Frame: Baseline
|
CAL is calculated by subtracting the gingival margin level from the probing depth.
|
Baseline
|
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Gingival index
Time Frame: Baseline
|
This measurement is based on the presence or absence of bleeding on gentle probing
|
Baseline
|
|
Gingival recession depth
Time Frame: Baseline
|
Gingival recession is the apical migration of the gingival margin away from the cemento-enamel junction (CEJ), resulting in the exposure of the root surface of a tooth.
|
Baseline
|
|
Periodontal pocket depth
Time Frame: Baseline
|
A pathologically deepened gingival sulcus around a tooth at the gingival margin.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2023
Primary Completion (Actual)
May 15, 2023
Study Completion (Actual)
June 25, 2023
Study Registration Dates
First Submitted
August 11, 2024
First Submitted That Met QC Criteria
August 11, 2024
First Posted (Actual)
August 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 2, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-DH-TS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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