Gingival ThicknessNCT06369506
Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks
A study testing GTmeasurement in people with Gingival Thickness, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Thickness
- What is being tested?
- GTmeasurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2022to 17 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers
- Healthy and normal periodontia
- Participants with no evidence of dental caries, crown shape alterations, or restorations affecting the occlusal edge in the teeth
- Presence of at least one tooth representing the anterior, molar and premolar regions in the maxillary and mandibular segments
Who cannot join
- Presence of gingival recession
- Presence of restorations affecting the crown shape and the occlusal edge of the tooth
- Using any medication that may affect the thickness of periodontal soft tissues (cyclosporine A, phenytoin or calcium channel blockers)
- History of orthodontic treatment
- Craniofacial asymmetry
- History of periodontal surgery
- Presence of abrasion or attrition in the incisal area of the teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Dentistry Department of Periodontology
Samsun, 55000
About this study
Official title: Classification of Gingival Phenotype at Different Landmarks
In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared.
Read the detailed description
The morphology of the soft tissue around the teeth (buccolingual GT and keratinized gingival width) is defined as the "gingival phenotype". One of the most important considerations when assessing gingival phenotype is the objective quantification of GT, and various methods have been used to measure GT. However, there is no clear consensus in the literature regarding the anatomical point where GT is measured in the buccal region. For this reason, it is thought that measurements made from different points also affect the classification of gingival phenotype. The aim of this study was to investigate the cut-off values in clinical parameters according to the average GT value of different measurement points and the GT value at a single point.
The study was designed as cross-sectional study. Participants were divided into two groups based on thin and thick gingival phenotypes in two different classifications. The first classification was based on the GT measurement taken from the base of the gingival sulcus, while the second classification was based on the average of GT measurements taken from three points (base of the gingival sulcus, 1 mm apical to the base of the gingival sulcus, and 2 mm apical to the base of the gingival sulcus. Other clinical and morphological parameters of the participants, who were divided into two groups (thin and thick) according to these classifications, were also measured with a digital caliper and periodontal probe. These parameters are keratinized gingival width (KGW), gingival groove depth (SD), crown width (CW), crown length (CL), crown width/crown length (CW/CL), papilla height (PH), gingival angle (GA). is. Among these parameters, the unit of measurement for GA is angle. CW/CL is the ratio. Other measurements were measured in mm. For all parameters, cut-off values were obtained through statistical measurements made according to two classifications. And these measurements were compared. In addition, the compatibility of the GT measurements of the three points with each other was also examined.
Participants Ondokuz Mayis University's Clinical Research Ethics Board approved the consent form and study protocol (210/2021). Participants with 1195 teeth sites, were enrolled in the study from September 2022 to August 2023. Participants were recruited from University Ondokuz Mayis included patients, dental/ hygiene students. A single calibrated examiner (SY) performed all clinical and morphological measurements.
- Conditions
- Gingival Thickness
- Being tested
- GTmeasurement
- Keywords
- gingiva, gingival phenotype, gingival thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTmeasurementDiagnostic test
GT was measured from the point corresponding to the base of the gingival sulcus and 1 mm and 2 mm apical to this point. If the GT was ≤1 mm, it was considered a thin phenotype, and if it was >1 mm, it was considered a thick phenotype.
| Study group | Role | What they receive |
|---|---|---|
| Gingival Phenotype Classification 1 | Active comparator | According to the GT of the point corresponding to the GT of the gingival sulcus base Receives: Diagnostic Test: GTmeasurement |
| Gingival Phenotype Classification 2 | Active comparator | According to the average GT of three points Receives: Diagnostic Test: GTmeasurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC).
Two different classifications compared for determining the gingival phenotype of 50 participants were evaluated for sensitivity and specificity using Receiver Operating Characteristic analysis (ROC). Gingival thicknesses for gingival phenotypes were measured in 1195 teeth. The data were recorded in the SPSS program, and ROC analysis was conducted. The Area Under the Curve (AUC) value is a general measure of classification performance in ROC analysis. AUC value ranges between 0 and 1, with a higher value indicating better performance. The result criterion in ROC analysis is used to evaluate the accuracy and discriminative power of classifications.
Measured: 1 month
Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis.
50 patients, 1195 teeth in the gingival region were measured in millimeters (mm) using a digital caliper with a precision of 0.001 mm. Kappa analysis was conducted on the collected data. Kappa analysis is used to assess the agreement between two or more measurements or between observers. In this study, the agreement between three points and the average GT value was evaluated using Kappa analysis. Kappa value ranges between -1 and 1: a Kappa value approaching 1 indicates excellent agreement between anatomical points. A negative Kappa value indicates worse agreement than random chance between anatomical points.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start10 Sep 2022
- Primary completion5 Aug 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival ThicknessStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if \>1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick".
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sude Yildirim, Ondokuz Mayıs University
- Investigators
- Sude Yildirim, DDS, Principal investigator, Ondokuz Mayis University Department of PeriodonthologyMuge Lutfioglu, PHD, Study director, Ondokuz Mayis University Department of Periodonthology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369506
- Sponsor's protocol ID
- PYO.DIS.1904 Protocol ID:4467
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.
PubMed 29926943Yildirim Bolat S, Lutfioglu M. Evaluation of gingival phenotype: the role of gingival thickness measurements from different vertical gingival levels. Clin Oral Investig. 2025 Jan 25;29(1):87. doi: 10.1007/s00784-024-06143-x.
PubMed 39856472
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Gingival Phenotype at Different Landmarks
- ClinicalTrials.gov ID
- NCT06369506
- Acronym / sponsor ID
- PYO.DIS.1904 Protocol ID:4467
- Conditions
- Gingival Thickness
- Keywords
- gingiva, gingival phenotype, gingival thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 17 Apr 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.
In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared.
Detailed description
The morphology of the soft tissue around the teeth (buccolingual GT and keratinized gingival width) is defined as the "gingival phenotype". One of the most important considerations when assessing gingival phenotype is the objective quantification of GT, and various methods have been used to measure GT. However, there is no clear consensus in the literature regarding the anatomical point where GT is measured in the buccal region. For this reason, it is thought that measurements made from different points also affect the classification of gingival phenotype. The aim of this study was to investigate the cut-off values in clinical parameters according to the average GT value of different measurement points and the GT value at a single point.
The study was designed as cross-sectional study. Participants were divided into two groups based on thin and thick gingival phenotypes in two different classifications. The first classification was based on the GT measurement taken from the base of the gingival sulcus, while the second classification was based on the average of GT measurements taken from three points (base of the gingival sulcus, 1 mm apical to the base of the gingival sulcus, and 2 mm apical to the base of the gingival sulcus. Other clinical and morphological parameters of the participants, who were divided into two groups (thin and thick) according to these classifications, were also measured with a digital caliper and periodontal probe. These parameters are keratinized gingival width (KGW), gingival groove depth (SD), crown width (CW), crown length (CL), crown width/crown length (CW/CL), papilla height (PH), gingival angle (GA). is. Among these parameters, the unit of measurement for GA is angle. CW/CL is the ratio. Other measurements were measured in mm. For all parameters, cut-off values were obtained through statistical measurements made according to two classifications. And these measurements were compared. In addition, the compatibility of the GT measurements of the three points with each other was also examined.
Participants Ondokuz Mayis University's Clinical Research Ethics Board approved the consent form and study protocol (210/2021). Participants with 1195 teeth sites, were enrolled in the study from September 2022 to August 2023. Participants were recruited from University Ondokuz Mayis included patients, dental/ hygiene students. A single calibrated examiner (SY) performed all clinical and morphological measurements.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if >1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick".
| Arm | Type | Receives |
|---|---|---|
| Gingival Phenotype Classification 1 | Active comparator | Diagnostic Test: GTmeasurementAccording to the GT of the point corresponding to the GT of the gingival sulcus base |
| Gingival Phenotype Classification 2 | Active comparator | Diagnostic Test: GTmeasurementAccording to the average GT of three points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smokers
- Healthy and normal periodontia
- Participants with no evidence of dental caries, crown shape alterations, or restorations affecting the occlusal edge in the teeth
- Presence of at least one tooth representing the anterior, molar and premolar regions in the maxillary and mandibular segments
Key exclusion criteria (7 listed)
- Presence of gingival recession
- Presence of restorations affecting the crown shape and the occlusal edge of the tooth
- Using any medication that may affect the thickness of periodontal soft tissues (cyclosporine A, phenytoin or calcium channel blockers)
- History of orthodontic treatment
- Craniofacial asymmetry
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 |
|---|---|---|
| GTmeasurementGT was measured from the point corresponding to the base of the gingival sulcus and 1 mm and 2 mm apical to this point. If the GT was ≤1 mm, it was considered a thin phenotype, and if it was >1 mm, it was considered a thick phenotype. | Diagnostic test | Gingival Phenotype Classification 1, Gingival Phenotype Classification 2 |
Primary outcome
Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC).
Time frame: 1 month
Two different classifications compared for determining the gingival phenotype of 50 participants were evaluated for sensitivity and specificity using Receiver Operating Characteristic analysis (ROC). Gingival thicknesses for gingival phenotypes were measured in 1195 teeth. The data were recorded in the SPSS program, and ROC analysis was conducted. The Area Under the Curve (AUC) value is a general measure of classification performance in ROC analysis. AUC value ranges between 0 and 1, with a higher value indicating better performance. The result criterion in ROC analysis is used to evaluate the accuracy and discriminative power of classifications.
Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis.
Time frame: 1 month
50 patients, 1195 teeth in the gingival region were measured in millimeters (mm) using a digital caliper with a precision of 0.001 mm. Kappa analysis was conducted on the collected data. Kappa analysis is used to assess the agreement between two or more measurements or between observers. In this study, the agreement between three points and the average GT value was evaluated using Kappa analysis. Kappa value ranges between -1 and 1: a Kappa value approaching 1 indicates excellent agreement between anatomical points. A negative Kappa value indicates worse agreement than random chance between anatomical points.
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 17 Apr 2024.
- Background: PubMed 29926943Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.
- Derived from this study: PubMed 39856472Yildirim Bolat S, Lutfioglu M. Evaluation of gingival phenotype: the role of gingival thickness measurements from different vertical gingival levels. Clin Oral Investig. 2025 Jan 25;29(1):87. doi: 10.1007/s00784-024-06143-x.
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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.
Sude Yildirim, DDS principal investigator
Ondokuz Mayis University Department of Periodonthology
Muge Lutfioglu, PHD study director
Ondokuz Mayis University Department of Periodonthology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTmeasurement in people with Gingival Thickness, run by Ondokuz Mayıs 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 4 inclusion and 7 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 17 Apr 2024. 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?
Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC). (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369506, which also lists 2 linked publications.
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 17 Apr 2024.