Volumetric Changes in Free Gingival Graft Procedures Taken With Different Techniques

October 20, 2023 updated by: Eda Cetin Ozdemir

Digital Evaluation of Volumetric Changes of Free Gingival Graft and Gingival Unit Graft With Indirect Method

The primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method.

To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deficiency of keratinized tissue includes mucogingival problems among different clinical entities. (Silva et al., 2010) There is no consensus on the minimum amount of attached gingiva required to maintain the health of the gums. However, there are many clinical situations that demonstrate the necessity of keratinized tissue. (Cevallos et al., 2020) (Agarwal et al., 2015) For example, if the attached gingiva is thin, it becomes difficult to perform adequate oral hygiene procedures and plaque. Inflammation and attachment loss are observed due to accumulation. (Gümüş and Buduneli, 2014) (Raoofi et al., 2019) Keratinized tissue width expresses the distance between the coronal margin of the gingival sulcus and the mucogingival line. It is considered to be the main factor in the management and protection of tissue health around natural teeth. (Agudio et al., 2019) Gingival recession refers to the apical displacement of the soft tissue margin from the cemento-enamel border. Oral hygiene and plaque with tooth sensitivity, root caries, unaesthetic appearance as well as loss of periodontal attachment causes retention. (Arzouman et al., n.d.) (Chambrone and Tatakis, 2015) In the treatment of gingival recession Many techniques have been described: Subepithelial connective tissue graft, stemmed grafts (coronally, laterally), free gingival graft (FGG), gingival unit graft (GUG). (Cevallos et al., 2020)(Sriwil et al., 2020). Although significant results are observed, there are different success rates between techniques. (Sriwil et al., 2020) FGG is used not only to cover the root surface but also to increase the width of keratinized tissue. It was first proposed by Nabers for this purpose. (Mörmann et al., 1981) Currently, the FGG's incompatible aesthetic and crude. It has many limitations due to its appearance. (Sriwil et al., 2020)

Due to the limitations of the FGG, there was a need for a new perspective on such phenomena. The vascular characteristics of the graft are important in terms of rapid capillary anastomosis with impaired vascularity of the recipient site. (Sriwil et al., 2020) Gingival sulcus, where thin blood vessels form a network and capillaries show numerous anastomoses is the place. (Jenabian et al., 2016) The vascular plexus of the gingiva, in terms of horizontal anastomoses feeding the marginal zone marginal and interdental tissues to benefit from better blood perfusion of the recipient area can be used, thus increasing the chances of survival of the graft. (Sriwil et al., 2020) (Yıldırım, 2015) The supracrestal part of the gingiva, which includes the marginal and papillary tissues, is included in the soft tissue graft taken to nourish the avascular root surface.

Studies have shown that the marginal, attached, and interdental gingival regions have significantly different vascular distributions. (Sriwil et al., 2020)

Due to these advantages of marginal and interdental tissues, the technique defined as Gingival Unit Graft (GUG) containing marginal and interdental papilla has emerged as an alternative approach to FGG. (Yıldırım, 2015) Kuru and Yıldırım, in their randomized controlled study comparing FGG and GUG in terms of keratinized tissue gain and root surface coverage, reported that DÜG gave better clinical results. (Dry oath Yıldırım, 2013)

G Power 3.1 (University Kiel, Germany) program was used to calculate the effect size. Effect size Free Gingival Graft in the study of Sriwil, Fakher (1) and an effect size of 2.12 d cohen was determined to be sufficient for significance. It was found that a total of 20 samples, at least 10 for each study group, was sufficient with a type 1 error of 0.05 and 99% power.

Free Gingival Graft was applied to 10 patients with keratinized mucosa deficiency, and Gingival Unit Graft was applied to 10 patients. Volumetric changes in the gingiva were measured both clinically and by scanner at the beginning and 6th months.

Study Type

Interventional

Enrollment (Actual)

20

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
      • Kahramanmaraş, Turkey
        • Kahramanmaraş Sütçü İmam University

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

No

Description

Inclusion Criteria:

  • Patients who are systemically healty,

Exclusion Criteria:

-

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Free Gingival greft Group

Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo free gingival graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months.

The keratinized tissue volume formed after the procedure will be evaluated.
Procedure: Free gingival unit, free gingival greft
The free gingival graft and the free gingival unit taken from the upper jaw palatal mucosa were sutured to the lower jaw anterior region.
Experimental: Gingival Unit Greft Group

Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo gingival unit graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months.

The keratinized tissue volume formed after the procedure will be evaluated.
Procedure: Free gingival unit, free gingival greft
The free gingival graft and the free gingival unit taken from the upper jaw palatal mucosa were sutured to the lower jaw anterior region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized gingival width
Time Frame: İnitial and postoperative 6 months
The change in keratinized tissue width after free gingival graft and gingival graft unit operations was evaluated.
İnitial and postoperative 6 months
Average gingival thickness change (mm)
Time Frame: İnitial and postoperative 6 months
The change in average gingival thickness change after free gingival graft and gingival graft unit operations was evaluated.
İnitial and postoperative 6 months

Collaborators and Investigators

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

Sponsor

Eda Cetin Ozdemir

Investigators

  • Study Chair: Eda Çetin Özdemir, Kahramanmaraş Sütçü İmam University

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)

February 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have other studies using this data

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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