The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft

August 7, 2018 updated by: serap karakış akcan, Istanbul Aydın University

The Effect Of Different Gingival Biotypes On Dimensional Stability Of Free Gingival Graft: A Comparative 6 Month Clinical Study

The aim of this study is to compare the effect of mesial and distal adjacent gingival biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of graft at 6 months postoperatively.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The concept of gingival and periodontal phenotype was established as a result of clinical observation of changes in facial keratinized tissue width and thickness .It has been reported that gingival or periodontal diseases may develop more frequently in patients with thin gingival biotypes and that thick-flat biotype in implant restorations is important in achieving a successful aesthetic treatment outcome.

Free gingival graft (FGG) is a mucogingival surgical procedure that is successfully used in the presence of inadequate keratinized gingival width and gingival recession. It is thought that factors that may adversely affect the continuity of graft nutrition may be effective in graft shrinkage. These reasons can be listed as follows; graft thickness, traumatic surgical procedure, graft dehydration, and suturing procedure.

There was no study investigating the effect of periodontal biotypes on graft contraction in the region adjacent to the FGG operation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In the mandibular incisor tooth / teeth, the attached keratinized gingival width is <1 mm,
  • No periodontal surgery has been performed previously on the involved tooth.
  • In the absence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.
  • Do not use any of the drug groups that may cause gingival overgrowth.

Exclusion Criteria:

  • Previous periodontal surgery in the operation area
  • Restoration of the buccal surface of the tooth and no pathology in the apical region of the tooth.
  • In the presence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1

Thin Biotype group has described as Group 1. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method".

The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thin biotype, the patient was assigned to the thin biotype group.

A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.
ACTIVE_COMPARATOR: Group 2

Thick biotype group has described as Group 2. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method".

The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thick biotype, the patient was assigned to the thick biotype group.

A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The graft shrinkage ratio
Time Frame: baseline - 6th months postoperatively
Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area
baseline - 6th months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
keratinized ginigival width
Time Frame: baseline - 6th months postoperatively
Keratinized Gingival Width(KGW) was measured using a lugol solution (10% potassium iodide and 5% iodine) with a manual caliper spaced 0.5 mm from the mid-buccal point of the tooth, the distance between the gingival margin and mucogingival junction from MTT, DTT and the teeth/tooth in operation area.
baseline - 6th months postoperatively

Collaborators and Investigators

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

Investigators

  • Study Director: serap karakış akcan, Phd, Istanbul Aydın University, Faculty of Dentistry

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.

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)

August 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (ACTUAL)

August 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

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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