Free Gingival Grafts (FGGs) in Mandibular Posterior Sites

Summary

In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects:

1. To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas.
2. To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.

Conditions

• Lack of Keratinized Tissue

Interventions

PROCEDURE

Partial thickness recipient bed

Flap will be separated by sharp dissection and elevated toward apical direction, leaving the periosteum covering the bone, and the elevated pedicle flap will be incised and removed.

PROCEDURE

Full thickness recipient bed

Full-thickness (mucoperiosteal) flap will be raised on the recipient bed to establish a denuded bone area. Two bone screws will be placed at the most apical border of the denuded bone.

DEVICE

Bone screw (FDA approved bone screw)

Two bone screws placed at the most apical border of the denuded bone after osteotomy.

PROCEDURE

Periosteal sutures

Interrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners.

PROCEDURE

Sling sutures

Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and the periosteum apically.

PROCEDURE

Sling sutures around screws

Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and each is apically looped around the corresponding apically positioned screw.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Tatakis Dimitris, DDS, PhD · The Ohio State University Graduate Periodontics Program Director

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-31

Primary Completion

2025-04-15

Completion

2025-04-15

FDA Device

Yes

Countries

• United States

Study Locations