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NCT Number: NCT03616197

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free gingival graft

Procedure

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.

Primary outcomes

  1. The graft shrinkage ratio

    Time frame: baseline - 6th months postoperatively

    Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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