Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations
试验速览
- 阶段
- 不适用
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Graft width, length and area
研究概览
简要总结
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:
- 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.
- To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 \ Race: Any Non-smokers: No use of any tobacco or nicotine-replacement products for the least 5 years
- •\ * 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)
- •\ * 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.
排除标准
- •\ * 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.
- •\ •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.
研究组 & 干预措施
Full-thickness bed preparation
Full-thickness bed preparation with bone screw placement for anchoring the sutures.
干预措施: Bone screw (FDA approved bone screw) (Device)
Partial-thickness bed preparation
Partial-thickness bed preparation for free gingival graft procedure.
干预措施: Partial thickness recipient bed (Procedure)
Partial-thickness bed preparation
Partial-thickness bed preparation for free gingival graft procedure.
干预措施: Periosteal sutures (Procedure)
Partial-thickness bed preparation
Partial-thickness bed preparation for free gingival graft procedure.
干预措施: Sling sutures (Procedure)
Full-thickness bed preparation
Full-thickness bed preparation with bone screw placement for anchoring the sutures.
干预措施: Full thickness recipient bed (Procedure)
Full-thickness bed preparation
Full-thickness bed preparation with bone screw placement for anchoring the sutures.
干预措施: Periosteal sutures (Procedure)
Full-thickness bed preparation
Full-thickness bed preparation with bone screw placement for anchoring the sutures.
干预措施: Sling sutures around screws (Procedure)
结局指标
主要结局
Graft width, length and area
时间窗: During the surgery, at the 1-, 2-, 4-, 8- week visits
Graft length and width will be confirmed after harvest and remeasured in situ, using a digital caliper, after completion of the surgical procedure. Subsequently, graft length and width will be measured on clinical images obtained at the post-op visits. A mirror image photo of the grafted site will be taken with a single-lens reflex camera and the dimension will be measured and analyzed with Image J software. Size markers will be used to calibrate image magnification. Graft area will be calculated from the length and width measurements.
次要结局
- Wound healing index(At the 3-day, 1-, 2-, 4-, 8- week visits)
- Biochemical wound assessment(At the 3-day, 1-, 2- week visits)
- Graft thickness(During the surgery, at the 8-week visits)
- Graft mobility(At the end of surgery, at the 8-week visits)
- Surgical time(During the surgery)
- OHIP-14(Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits)
- Pain assessment.(At the 3-day, 1-, 2-, 4-, 8- week visits)
- Operator-centered outcomes(Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases)