Free Gingival Grafts (FGGs) in Mandibular Posterior Sites

The Ohio State University

Status: Active, not recruiting

Conditions: Lack of Keratinized Tissue

Treatments: Procedure: Periosteal sutures; Procedure: Full thickness recipient bed; Device: Bone screw (FDA approved bone screw); Procedure: Sling sutures; Procedure: Sling sutures around screws; Procedure: Partial thickness recipient bed

Study type: Interventional

Funder types: Other

Identifiers

NCT04099680

2019H0350 (Other Identifier)

fsafggrct2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

A) Target population: Patients whether edentulous or dentate or treated with root-form dental implants, who need FGG on the buccal aspect of the mandibular posterior area.

Inclusion criteria <Demographic> Race: Any Non-smokers: No use of any tobacco or nicotine-replacement products for the least 5 years

<Medical history>

• Physically and mentally healthy with no contraindication for periodontal surgery
• American Society of Anesthesiologists: ASA-1 or ASA-2
• Clinical (Oral) conditions: Periodontally healthy patients with no contraindication for free gingival graft procedure (donor and recipient sites)

<Other>

• Patients who need free gingival graft in the mandibular posterior area.
• Patients who are able and willing to provide informed consent
• Patients who are able to receive surgery on Tuesday.

Exclusion criteria <Medical history>

• Smokers or users of nicotine replacement products
• Patients with any history of soft tissue surgery (grafting) in the area to be treated
• Patients with contraindication for periodontal soft tissue surgery, including an anatomical location of mental nerve that may restrict preparation of 10x10mm recipient bed
• Patients with contraindication, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
• Patients with inadequate donor site anatomy.
• Patients with uncontrolled diabetes (glycemic level > 110mg/l and HbA1c > 6%)
• Patients with drug or alcohol abuse
• Pregnant or lactating women
• Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
• Other systemic conditions or medications affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases, phenytoin, cyclosporine, dihydropyridines, etc.

<Dental>

•Poor oral hygiene (PlI>2) 28

Subjects will be exited from the study immediately upon:

• Change of mind regarding participation
• Development of acute dental/oral conditions requiring treatment
• Development of a condition requiring treatment that conflicts with the exclusion criteria listed above
• Failure to comply with study instructions/requirements/appointments

B) Target population: Operators

Inclusion criteria

•2nd and 3rd year residents at Division of Periodontology, The Ohio State University, in good standing.

Exclusion criteria

•Residents who don't want to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Partial-thickness bed preparation

Active Comparator group

Description:

Partial-thickness bed preparation for free gingival graft procedure.

Treatment:

Procedure: Periosteal sutures

Procedure: Sling sutures

Procedure: Partial thickness recipient bed

Full-thickness bed preparation

Experimental group

Description:

Full-thickness bed preparation with bone screw placement for anchoring the sutures.

Treatment:

Procedure: Periosteal sutures

Procedure: Sling sutures around screws

Device: Bone screw (FDA approved bone screw)

Procedure: Full thickness recipient bed