Influence of Electrical Stimulation on Palatal 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 aim of this present study is to evaluate the clinical and patients-centered parameters of electric stimulation 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:
- Sham Group - Free Gingival Graft (n = 22): Atraumatic extraction surgery and free gingival graft for sealing the entrance of the alveolus associated with SHAM electrical stimulation simulation.
- Test Group - Free Gingival Graft + Electric stimulus (n = 22): Atraumatic extraction surgery with placement of a free gingival graft to seal the entrance of the alveolus associated with electrical stimulation 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 9 millimeters in diameter will be used. This mold 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).
For electrical stimulation, a unit consisting of a signal generator (Keysight Technologies., Inc., Santa Rosa-CA, USA), a power supply (Keysight Technologies., Inc., Santa Rosa-CA, USA) and circuit board will be used. Conductive electrodes for electrical current application will be applied to the palatal donor area on each side of the wound at a distance of 3 mm from the wound edge. An alternating current of 100 microamperes (μA) at 9 kilohertz (kHz), will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, five consecutive days. The electric current will have its visualization optimized through an oscilloscope. Patients randomized to the Control Group (SHAM) will receive the simulation of the electrical stimulation (ES) process.
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 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;
- •Patient using a pacemaker.
研究组 & 干预措施
Sham Group - Free Gingival Graft + Sham Electric Stimulation
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 9 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 SHAW Group will receive the simulation of the electrical stimulation process, thus non current will be applied.
干预措施: Free Gingival Graft (Procedure)
Sham Group - Free Gingival Graft + Sham Electric Stimulation
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 9 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 SHAW Group will receive the simulation of the electrical stimulation process, thus non current will be applied.
干预措施: SHAM Electric stimulation (Device)
Test Group - Free Gingival Graft + Electric Stimulation
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 9 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. Conductive electrodes for electrical current application will be applied to the palatal donor area on each side of the wound at a distance of 3 mm from the wound edge. An alternating current of 100 microamperes (μA) at 9 kilohertz (kHz), will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, five consecutive days.
干预措施: Free Gingival Graft (Procedure)
Test Group - Free Gingival Graft + Electric Stimulation
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 9 mm and 2 mm thickness. After free gingival graft removal from palate, it will be adjusted to the entrance of the socket and sutured. Conductive electrodes for electrical current application will be applied to the palatal donor area on each side of the wound at a distance of 3 mm from the wound edge. An alternating current of 100 microamperes (μA) at 9 kilohertz (kHz), will be distributed in order to traverse the operated area. A single application of electrical stimulation will be given for 120 seconds, five consecutive days.
干预措施: Electric Stimulation (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
- Postoperative discomfort(7 days)
- Number of analgesics(2 weeks)
- Tissue edema(7 days)
- Scar and tissue colorimetry(30 days)
- Epithelialization(7 days)
- Tissue thickness(90 days)
- Oral Health Impact Profile(2 weeks)
研究者
Mauro Pedrine Santamaria
Assistant professor
Universidade Estadual Paulista Júlio de Mesquita Filho