Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks

NCT06369506 | Completed

• 1 other identifier: PYO.DIS.1904 Protocol ID:4467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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, which is frequently used in the literature. And these two classifications were compared.

Conditions

Gingival Thickness

Keywords

gingiva; gingival phenotype; gingival thickness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 month

Study Arms (2)

Gingival Phenotype Classification 1

ACTIVE COMPARATOR

According to the GT of the point corresponding to the GT of the gingival sulcus base

Diagnostic Test: GTmeasurement

Gingival Phenotype Classification 2

ACTIVE COMPARATOR

According to the average GT of three points

Diagnostic Test: GTmeasurement

Interventions

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.

Gingival Phenotype Classification 1; Gingival Phenotype Classification 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University Faculty of Dentistry Department of Periodontology

Samsun, 55000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29926943 BACKGROUND

• Yildirim 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.

  PMID: 39856472 DERIVED

Study Officials

• Sude Yildirim, DDS

  Ondokuz Mayis University Department of Periodonthology

  PRINCIPAL INVESTIGATOR

• Muge Lutfioglu, PHD

  Ondokuz Mayis University Department of Periodonthology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: 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".

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: September 10, 2022
• Primary Completion: August 5, 2023
• Study Completion: December 17, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

TU (1)