Influence of Enamel Matrix Derivative (Emdogain®) on Palate Wound Healing. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Remaining wound area
研究概览
简要总结
The objective of this study is to evaluate clinical and patients-centered parameters of 3-month outcome of the enamel-derived matrix (EMD) application on wound healing process of the donor palatal area after free gingival graft (FGG) removal.
详细描述
This is a randomized, parallel, double-blind clinical trial. The population that will be evaluated in this is study will be select at Science and Technology Institute - ICT-Sao Jose dos Campos, College of Dentistry.
Patients will be assigned to one of the treatments groups:
- Control Group - Free Gingival Graft (n = 22): Atraumatic extraction surgery and free gingival graft for sealing the entrance of the alveolus
- Test Group - Free Gingival Graft + EMD (n = 22): Atraumatic extraction surgery with placement of a free gingival graft to seal the entrance of the alveolus associated with EMD in the open wound on the palate.
All surgeries will be performed by the same expert periodontist (MMVM). A blade 15c (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. With the aim to ridge preservation after tooth extraction the socket will be sealed with a free gingival graft removed from the palate. For the free gingival graft removal, a circular template of 8 millimeters in diameter will be used. This stent has the objective of standardizing the palatal graft removal ensuring the wounds will have always the same size. After the circular incision, the graft will be removed with a thickness of 2 millimeters. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil, São José dos Campos - SP).
After the graft position, EMD will be applied immediately after the graft removal surgical procedure on the palatal donor area, leaving it in contact with the wound for 5 min. In sequence, it will be covered with an individualized acetate plate that will extend throughout the palatal area and be in position for 2 hours after the procedure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least 18 years of age, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index of less than 25% (O'Leary et al., 1972);
- •Patients with no morphological or pathological changes in the donor palatine region;
- •Patients who present an indication of exodontia and with ridge preservation indication for future implantation of implants;
- •The tooth included in the study, as well as the adjacent teeth, do not present a loss of periodontal insertion;
- •Patients who agreed to and signed the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).
排除标准
- •Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
- •Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- •Smokers patients;
- •Pregnant or lactating patients;
- •Patients who had had periodontal surgery on the study area;
- •Patients who present opportunistic oral lesions mainly colonized the palate region;
研究组 & 干预措施
Control Group - Free Gingival Graft
With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 8 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. Patient randomized to the Control Group will not receive any kind of treatment in the palatal region.
干预措施: Free gingival graft (Procedure)
Test Group - Free Gingival Graft + EMD
With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 8 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. EMD will be applied immediately after the graft removal surgical procedure on the palatal donor area, leaving it in contact with the wound for 5 min. In sequence, it will be covered with an individualized acetate plate that will extend throughout the palatal area and be in position for 2 hours after the procedure
干预措施: Free gingival graft (Procedure)
Test Group - Free Gingival Graft + EMD
With the aim to ridge preservation after condemned tooth extraction, the socket will be sealed with a free gingival graft removed from the palate. The tooth will be extracted through the use of appropriate instruments in order to obtain a minimally traumatic exodontia. After the exodontia, curettage and irrigation of the dental socket will be performed. The free gingival graft will be removed from the donor palatal area with a circular incision of 8 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. EMD will be applied immediately after the graft removal surgical procedure on the palatal donor area, leaving it in contact with the wound for 5 min. In sequence, it will be covered with an individualized acetate plate that will extend throughout the palatal area and be in position for 2 hours after the procedure
干预措施: Enamel Matrix Derivate (Device)
结局指标
主要结局
Remaining wound area
时间窗: 7 days
The defect area will be measured after 7 post-operative days. For this, standardized photography will be taken ( in terms of brightness, distance and angle). A scale will be used as a reference to measure the area. These photographs will be exported to image software (Image J-NIH, Bethesda, USA) and the wound area will be measured in square millimeters (mm2) (Dias et al. 2015).
次要结局
- Scar and tissue colorimetry(30 days)
- Epithelialization(7 days)
- Oral Health Impact Profile(2 weeks)
- Postoperative discomfort(7 days)
- Number of analgesics(2 weeks)
- Tissue edema(7 days)
- Tissue thickness(90 days)
研究者
Mauro Pedrine Santamaria
assistant professor
Universidade Estadual Paulista Júlio de Mesquita Filho