TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE

July 28, 2022 updated by: RASUL GULIYEV, Ondokuz Mayıs University

COMPARISON OF THE CONVENTIONAL AND MODERN TECHNIQUES USED IN CLINICAL EVALUATION AND CLASSIFICATION OF THE GINGIVAL PHENOTYPE.

This study evaluates the 4 different techniques used in clinical measurement of gingival phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4) Translucency Colorvue Biotype Probe.

The aim of our study is to evaluate the reliability and applicability of the current examination methods recommended in order to improve the deficiencies of the traditional examination methods used in the evaluation of the gingival phenotype.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 55200
        • Ondokuz Mayis University Faculty of Dentistry

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy individuals,
  • Periodontal healthy individuals with a whole mouth plaque score of 15% and a whole mouth bleeding score of less than 15%,
  • Individuals who have not undergone periodontal treatment (subgingival curettage, gingivectomy, crown lengthening, etc.) in the last 6 months,
  • Absence of dental compensations of skeletal malocclusion.

Exclusion Criteria:

  • Individuals who smoke and have a history of smoking,
  • Individuals who have undergone orthodontic treatment,
  • Individuals using drugs that may cause gingival hyperplasia (immunosuppressive drugs, calcium channel blockers, anticonvulsant drugs, etc.)
  • Individuals who are in pregnancy or lactation period,
  • Presence of structural defects, crowns or large restorations in the maxillary anterior teeth to be measured,
  • The presence of missing or supernumerary teeth in the maxillary anterior teeth to be measured,

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gingival phenotype
A Periodontal probe was used to differentiate between thick and thin phenotypes and Color coded Biotype Probe was used to classified the phenotype as thin, moderate, thick and very thick phenotypes. Endodontic File and Florida probe were used to measure the gingival thickness.
Device: Gingival thickness
After the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and reliability of techniques
Time Frame: 1 day
Comparison between the conventional techniques(Periodontal probe and Endodontic file) and modern techniques(Colorvue Biotype Probe and Modified Florida Probe) in terms of reliability and feasibility.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of gingival thickness and the width of the keratinized tissue
Time Frame: 1 day
To determine the cut-off dimensions by evaluating the gingival thickness at 3 different points.
1 day

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

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)

April 25, 2021

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ACTUAL)

May 25, 2022

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (ACTUAL)

July 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PYO.DIS.1904.21.008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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