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Completed

NCT Number: NCT06369506

Evaluation of Gingival Thickness Measurement at Different Anatomical 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.

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Key information

Conditions

Gingival Thickness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University Faculty of Dentistry Department of Periodontology

Samsun, 55000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

GTmeasurement

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Classification of Gingival Phenotype at Different Landmarks

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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