NCT04099680

Free Gingival Grafts (FGGs) in Mandibular Posterior Sites

Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

While the presence of a sufficient size of keratinized oral mucosa is favorable, the surgical procedure to increase the size is technically difficult. In the traditional way, preparation of the gum bed for a graft tissue is done with partial-thickness flap elevation, in which part of the mucosa and submucosa, but not the periosteum (dense fibrous membrane covering the surface of bones), are separated from underneath bone. In the traditional method of gum bed preparation, separation of the mucosa and submucosa from underneath periosteum and bone should be done with extremely caution to avoid damaging the periosteum. Therefore, the traditional method of gum bed preparation is not only time consuming but also problematic because of more bleeding when compared to full thickness flap elevation, in which the mucosa and submucosa together with the periosteum are separated from underneath bone. In order to stabilize gum graft on bone surface, a new technique is applied in this study by using two bone screws as anchorage to fastened the graft on the exposed bone through suturing. In the present study, we will compare patient quality of life, operator satisfaction, and differences in surgical wound healing between these two different bed preparations. The results of this study could help establish a more patient- and operator-friendly surgical protocol for the use of gum graft to increase the width of keratinized oral mucosa.

Conditions

• Lack of Keratinized Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-31
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2019-09-23
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study