SmilingEPHSNCT06554379
The Effect of Periodontal Health on Smile
An observational study of Smiling and Gingival Diseases, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Smiling, Gingival Diseases
- What is being tested?
- Periodontal health and gingivitis
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 25 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 108 systemically healthy individuals between 13 and 33 years of age
Who may be able to join
- No systemic disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University
Bolu, Bolu, 14030
About this study
Official title: 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.
- Conditions
- Smiling, Gingival Diseases
- Being tested
- Periodontal health and gingivitis
- Keywords
- gingivitis, periodontal health, smile
- Medical subject headings
- Smiling, Gingival Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal health and gingivitisOther
The presence or absence of periodontal disease in the gingiva was determined.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal health | It includes gingival healthy individuals without any periodontal disease. Receives: Other: Periodontal health and gingivitis | |
| Gingivitis | It includes individuals with gingivitis. Receives: Other: Periodontal health and gingivitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Gingival display
The gingival displays were measured by measuring the distances from the zenith points to the vermilion border
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline
Secondary outcomes (6)
Plaque index
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth
Measured: Baseline
Gingival index
This measurement is based on the presence or absence of bleeding on gentle probing
Measured: Baseline
Bleeding on probing
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.
Measured: Baseline
Periodontal pocket depth
A pathologically deepened gingival sulcus around a tooth at the gingival margin.
Measured: Baseline
Clinical attachment level
CAL is calculated by subtracting the gingival margin level from the probing depth.
Measured: Baseline
Gingival recession depth
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start15 May 2023
- Primary completion15 May 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmilingStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554379
- Sponsor's protocol ID
- AIBU-DH-TS
- Acronym
- EPHS
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Periodontal Health on Smile Parameters: a Cross-Sectional
- ClinicalTrials.gov ID
- NCT06554379
- Acronym / sponsor ID
- EPHS / AIBU-DH-TS
- Conditions
- Smiling, Gingival Diseases
- Keywords
- gingivitis, periodontal health, smile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal health | – | Other: Periodontal health and gingivitisIt includes gingival healthy individuals without any periodontal disease. |
| Gingivitis | – | Other: Periodontal health and gingivitisIt includes individuals with gingivitis. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 108 systemically healthy individuals between 13 and 33 years of age
Key inclusion criteria (1 listed)
- No systemic disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal health and gingivitisThe presence or absence of periodontal disease in the gingiva was determined. | Other | Gingivitis, Periodontal health |
Primary outcome
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.
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.
Gingival display
Time frame: Baseline
The gingival displays were measured by measuring the distances from the zenith points to the vermilion border
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)
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
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
6 secondary outcomes
Plaque index
Time frame: Baseline
Gingival index
Time frame: Baseline
Bleeding on probing
Time frame: Baseline
Periodontal pocket depth
Time frame: Baseline
Clinical attachment level
Time frame: Baseline
Gingival recession depth
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smiling and Gingival Diseases, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratinized gingival thickness (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.