Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks

April 12, 2024 updated by: Sude Yildirim, Ondokuz Mayıs University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • Turkey
      • Samsun, Turkey, 55000
        • Ondokuz Mayis University Faculty of Dentistry Department of Periodontology

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gingival Phenotype Classification 1
According to the GT of the point corresponding to the GT of the gingival sulcus base
Diagnostic test: GTmeasurement
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.
Active Comparator: Gingival Phenotype Classification 2
According to the average GT of three points
Diagnostic test: GTmeasurement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Sude Yildirim, DDS, Ondokuz Mayis University Department of Periodonthology
  • Study Director: Muge Lutfioglu, PHD, Ondokuz Mayis University Department of Periodonthology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 10, 2022

Primary Completion (Actual)

August 5, 2023

Study Completion (Actual)

December 17, 2023

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PYO.DIS.1904 Protocol ID:4467

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Gingival Thickness

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe