Effect of High-Frequency Vibration on Periodontal Tooth Mobility
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Tooth Mobility
研究概览
简要总结
According to the CDC, approximately 47% of the population suffers from moderate or severe periodontitis. A byproduct of periodontal disease is loss of the alveolar bone surrounding the natural tooth root as well as around the dental implant in cases of peri-implantitis, and if allowed to proceed far enough, can cause mobility and eventual loss of the tooth or implant. Traditional and time-tested methods of treating periodontitis involve a meticulous mechanical cleaning of the root surfaces to remove the causing factors, both above and below the gumline. This reduction or elimination of the etiologic factors that trigger the pathologic and damaging immune response is very effective at reducing the inflammation. High Frequency Vibration (VPro+), when used as an adjunctive therapy following traditional treatment for periodontitis where the chronic inflammation has been lowered, controlled or eliminated has the potential to enhance the mechanical properties of the bone by increasing bone density by way of a low-risk, non-invasive, self-applied therapy that is patient-friendly and affordable. Improvement in bone density can translate clinically to lowering of tooth mobility, and lessening the chance of orthodontic relapse after orthodontic therapy. It is further hypothesized that, if conducted in an environment of low or nonexistent periodontal inflammation, VPro+ therapy may also contribute to enhanced the degree of bone fill after healing of angular periodontal bone defects and low-grade furcation involvements, and as thus may turn out to be a less invasive and more affordable option to periodontal bone grafting surgery, the current standard of care for those particular situations. The goal is to conduct a randomized clinical trial using patients in our graduate periodontology program to test the efficacy of high frequency vibration in improvement of tooth mobility and other periodontal indices in test group versus control group.
详细描述
Background Bio stimulation of hard and soft tissue to enhance or accelerate healing is an exciting area of inquiry with the potential to have broad clinical application in periodontics. The external application of energy in the form of light (e.g. Lasers or broad-spectrum light) (1) or mechanical waves (ultrasonic or high-frequency vibration) (2),(3) has shown efficacy in creating clinical changes in hard and soft tissue that can be very positive and beneficial or the contrary, depending on the application and the existing initial conditions present. According to the CDC, approximately 47% of the population suffers from moderate or severe periodontitis. (4) This chronic disease is a systemic disease that is fundamentally connected to other diseases of inflammation, including diabetes, arthritis, Alzheimer's Disease, and heart disease(5) and is, therefore, a disease that should not be taken lightly. A by-product of periodontal disease is the loss of the alveolar bone surrounding the natural tooth root as well as around the dental implant in cases of peri-implantitis, and if allowed to proceed far enough can cause mobility and eventual loss of the tooth or dental implant. The chronic inflammatory process results in the destruction of both hard and soft tissues and is triggered in the susceptible host by microbial biofilm and mineralized biofilm (i.e. calculus).
Traditional and time-tested methods of treating periodontitis involve a meticulous mechanical cleaning of the root surfaces to remove the causing factors, both above and below the gum line. This reduction or elimination of the etiologic factors that trigger the pathologic and damaging immune response is very effective at reducing inflammation. High-Frequency Vibration (VPro+), when used as an adjunctive therapy following traditional treatment for periodontitis wherein the chronic inflammation has been lowered, controlled, or eliminated has the potential to enhance the mechanical properties of the bone by increasing bone density (3) by way of a low-risk, non-invasive, self-applied therapy that is patient-friendly and affordable. Improvement in bone density can translate clinically to lowering (i.e. improvement) of tooth mobility and lessening the chance of orthodontic relapse after orthodontic therapy. It is further hypothesized that, if conducted in an environment of low or nonexistent periodontal inflammation, VPro+ therapy may also contribute to enhancing the degree of bone fill after healing of angular periodontal bone defects and low-grade furcation involvements, and as thus may turn out to be a less invasive and more affordable option to periodontal bone grafting surgery, the current standard of care for those particular situations.
Tissue Response to VPro+ Application in areas of Inflammation It is clear from previous research into the use of the VPro+ to accelerate and enhance orthodontic therapy that the cellular tissue response in areas of inflammation is essentially the opposite to that which occurs in areas of no inflammation. (3) Again, whether the response is beneficial depends on the intended application at hand. VPro+ therapy in areas of inflammation caused by orthodontic tooth movement forces stimulates osteoclastic activity to accelerate the resorption of bone, making the bone "softer" and thus allowing for more rapid tooth movement through these softer areas. On the contrary, when considering periodontitis, it is critical to understand that the inflammation must first be lowered and controlled so that the tissue response is anabolic, not catabolic. Our goal in periodontal therapy is to preserve, regenerate and strengthen the periodontal tissues, including the bone. So, a mandatory precursor therapy to using the VPro+ in cases of periodontitis is to first perform periodontal therapy and demonstrate and document a reduction or elimination of chronic inflammation by way of a Re-Evaluation Examination.
Expected result of this study We expect that VPro+ will safely enhance the condition of the periodontal tissues around the teeth in periodontal patients in a periodontal recall program and that this enhancement will improve the long-term prognoses of the teeth.
Study design This randomized, single blind clinical trial will enroll from 10-20 subjects from an established graduate periodontology program who have previously been treated for periodontal disease and are now in a periodontal recall program. These patients will be randomized between the two groups. The evaluator examining the patients will be blinded to the group assignment as the coding will be kept separate from the clinical patient record. The subjects, however, will be aware of whether they are in the treatment or no-treatment control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Graduate student and PI were double-blinded
入排标准
- 年龄范围
- 30 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overall health must be either ASA Classification I or II. (ASA I: A normal healthy patient; ASA II: A patient with mild systemic disease) (Doyle, Goyal, & EH, 2022),
- •Patient must have a recent history of treated periodontal disease and currently be compliant with a periodontal recall maintenance program supervised by a periodontal specialist,
- •Patient age must be between 30 and 85 years,
- •No gender or ethnic restrictions,
- •Patient must have at least one tooth with Miller's Class I mobility,
- •Patients should have posterior dentition such that they can firmly hold the vibrating device, this likely implies the presence of two or more posterior teeth in all four quadrants.
排除标准
- •Patients on medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers,
- •Periodontal recall patients who have a history of non-compliance with the recommended recall interval (usually three to four months),
- •Pregnant women,
- •Uncontrolled diabetes,
- •Subjects with current caries activity,
- •Vulnerable subjects as per the Research Ethics Office or HREB definitions.
结局指标
主要结局
Tooth Mobility
时间窗: 3 months of intervention after use of device for 5 minutes per night
Change in tooth mobility as denoted by Periotest value or Miller's grade of mobility
次要结局
- Bone mineral density (BMD)(3 months of intervention after use of device for 5 minutes per night)
