A Randomized Clinical Trial on the Effect of Nanocrystal Gels on the Management of Peri-implant Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 390
- 主要终点
- Change in Bleeding on probing index
研究概览
简要总结
Dental implants are a well-accepted treatment for replacing missing teeth, due to excellent patient satisfaction regarding function, aesthetics, and comfort, as well as their long-term survival. However, the accumulation of bacterial biofilm on implants changes their surface biocompatibility and initiates peri-implant diseases, such as peri-implant mucositis and peri-implantitis. Professional cleaning of the implant surface is necessary to remove the biofilm and facilitate healing within the surrounding tissue. Prophylaxis pastes can be used in dental clinics to assist the mechanical removal of biofilm by dental professionals. However, these pastes can contain abrasives that detrimentally affect the surface stability and chemical properties of the implant surfaces.
ImplanTreat® and Neophylaxis® are novel nanocrystal gels designed for implants' professional cleaning, under surgical and non-surgical procedures respectively. These products present high biocompatibility proprieties that can improve peri-implant bone healing. Moreover, they don't contain abrasives, or fluoride, which preserves the implant surfaces. The researchers hypothesize that professional implant cleaning with Neophylaxis® or ImplanTreat® results in a greater reduction of peri-implant inflammation and dental plaque accumulation in comparison to cleaning without any product. Accordingly, the purpose of this study is to verify if Neophylaxis® and ImplanTreat® enhance the efficacy of professional cleaning and preserve implant surface roughness.
The researchers will randomly divide the recruited participant into two groups depending on the clinical diagnosis, each patient will be either recruited in peri-implant mucositis group (Group I), or in peri-implantitis group (Group II). Each patient in the group I will be assigned randomly to receive either implant cleaning with Neophylaxis® or cleaning without. Similarly, each patient in group II will be assigned randomly to receive either implant cleaning with ImplanTreat® or cleaning without. No participant will be aware of his allocation before the end of data collection. In each evaluation session, The researchers will examine the participants' implants and evaluate the removal of biofilm as well as the improvement of the peri-implant tissue health and bone level. The researchers will then analyze and compare the results obtained from each study group.
详细描述
Background:
Oral hygiene and regular maintenance are crucial to sustaining healthy peri-implant tissues. However, current available prophylaxis products and toothpaste tend to contaminate and abrade the surface of implants, due to the high affinity of humectants, thickeners and surfactants to the implant surface and the high abrasiveness of silica microparticles used in these products. Nanocrystalline magnesium phosphate (NMP) gel, a novel inorganic colloidal suspension, is the result of 7 years of research in Dr. Faleh Tamimi's laboratory in collaboration with researchers from McGill University. It is a hydrogel with unique biocompatibility that can improve peri-implant bone healing. The NMP gel forms highly stable inorganic colloidal suspensions with interesting rheological properties (i.e. thixotropy) that are ideal for toothpaste and prophylaxis paste applications and do not require the addition of organic thickeners. The product contains magnesium phosphate (3.02% w/v) and sodium phosphate (8.23% w/v) in 3 mL syringe.
Hypotheses (null):
Professional cleaning of implant surfaces with NMP prophylactic gel during maintenance visits will result in similar reductions of gum redness, bleeding and plaque scores after 4 weeks than implant surfaces cleaned without gel.
Professional cleaning with NMP treatment gel of implant surfaces diagnosed with peri-implantitis will result in similar reductions of peri-implant probing depth, bleeding, plaque scores and suppuration after 4 weeks, as well as improved bone levels after 6 months, compared to implant surfaces, cleaned without gel.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients aged 18 years and older.
- •Patients with upper or lower implant-supported/retained prostheses.
- •The implant should be in function for 12 months or more.
- •To be included in group I, peri-implant mucositis should be diagnosed.
- •To be included in group II, peri-implantitis should be diagnosed.
排除标准
- •Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment;
- •Patients receiving medications known to induce gingival hyperplasia;
- •Patients who have taken systemic antibiotics less than 3 months prior to baseline;
- •Patients with prosthetic factors that prevent clinical measurements
- •Implants with technical complications, such as poor marginal contour or any type of prosthetic complication that would be a local contributing factor to chronic inflammation.
- •Peri-implant bone loss 50% [47]
- •Presence of any acute oral infection.
- •Presence of uncontrolled diabetes or other systemic diseases.
- •Intravenous bisphosphonates
- •Oral bisphosphonate intake for more than 3 years.
结局指标
主要结局
Change in Bleeding on probing index
时间窗: 4 weeks, 6 months, 1 year
semi-quantitative assessment of bleeding after probing around each implant 0 = No bleeding 1. Isolated minimal bleeding spots 2. Blood forming a confluent red line on the margin 3. Heavy or profuse bleeding
Change in Probing depth (PD)
时间窗: 4 weeks, 6 months, 1 year
probing depth in mm of peri-implant tissues around each implant
次要结局
- Crestal bone level (CBL)(6 months, 1 year)
- modified plaque index(4 weeks, 6 months, 1 year)
- Modified Gingival Index(4 weeks, 6 months, 1 year)
- gingival suppuration after probing(4 weeks, 6 months, 1 year)
研究者
Robert Durand
Associate Professor
Université de Montréal