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临床试验/NCT05442034
NCT05442034招募中1 期

Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects

Nova Southeastern University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
36
试验地点
1
主要终点
Clinical Attachment Changes

研究概览

简要总结

Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.

详细描述

Alveolar bone crest is considered normal when it is found at a distance of 0.4- 1.97mm from the cementoenamel junction (CEJ) of the tooth. Chronic inflammation resulting from periodontal disease (PD) may lead to change in this architecture and formation of osseous defects. The variation in the form of these defects may be influenced by the occlusal stresses that the tooth is subjected to or the original form of the alveolar process in a localized area.

While Glickman chose to classify the osseous defects into "Osseous craters, intra-bony defects, bulbous osseous contours, hemi-septa, inconsistent margins and ledges"; Pritchard classified them as "interproximal craters, inconsistent margins, hemi-septa, furca invasions, intra-bony defects and a combination of these defects". Identifying the type of defect is of utmost importance. Intra-bony defects found in the interproximal areas can be one-wall, two-walls, or three-walls defects, depending on how many walls are remaining. On the other hand, when the inter-radicular bone is lost, its commonly classified as grade I, grade II, or grade III furcation.

Successful regeneration of the intra-bony defects will be accompanied by clinical attachment gain, decreased pocket depth, radiographic bone height gain, and improved periodontal health, to reach this goal, several types of bone grafts, membranes, biologics and/or combinations, have been investigated for potential application and, they proved success over short- and long-term.

Flemming et al. 1998, tested the bone gain following open flap debridement (OFD) versus allogeneic bone graft. The group that received allogenic bone graft had higher bone gain compared to the OFD group at 6 months (2.2mm vs 1.2mm) and 3 years (2.3mm vs 1.1mm) (P <0.05). Comparable results were found when A. Sculean et al 2004, tested CAL gain when enamel matrix proteins (EMD) was used versus OFD; having 1.3mm of CAL gain at 5 years when the latter was used versus 2.9mm when the former was used (p<0.001). Eickholz et al. 2004, tested the use of bioabsorbable membrane for the treatment of intra-bony defects with guided tissue regeneration. Attachment height gain was stable at 12- and 60-months follow up (3.5mm and 2.2mm). In a case series, Kim et al. compared the clinical attachment gain in 12 pairs of intra-bony defects in 12 subjects. One side was randomly assigned to receive GTR with a bioabsorbable membrane (Polyglactin) (control), while the contralateral received non-resorbable membrane (e-PTFE) (test). Both groups yielded significant clinical attachment gain at 6 (C6 and T6) and 60 months (C60 and T60), (C6: 2.6 ± 1.4 mm; C60: 1.6 ± 1.5 mm; T6: 3.0 ± 1.7 mm; T60: 3.0 ± 0.7 mm).

Emdogain is a biologic material that consists of hydrophobic enamel matrix proteins extracted from developing embryogenic enamel of porcine origin. It was first tested on monkeys for ability to regenerate buccal dehiscence defects and resulted in complete regeneration of the defect. It was later used in conjunction with Modified Widman Flap (MWF) and compared to MWF with placebo, for the regeneration of intra-bony defects in human subjects. At 36 months, the EMD group yielded significantly higher bone gain (2.2 mm vs 1.7 mm), respectively.

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
Single (Participant)

盲法说明

Participants will not know which biologic agent (rh-PDGF or EMD) is being used.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age is 18 years old and older
  • Absence of relevant medical conditions
  • Availability for 6-month follow-up
  • Subjects who recently have received scaling and root planing due to periodontal disease
  • Single-rooted and multi-rooted teeth in either the maxilla or the mandible.
  • Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm.
  • Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects)
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <20% at surgery

排除标准

  • Female patients who are pregnant or planning to be pregnant during the period of the study
  • Heavy smokers (>10 cigarettes a day)
  • Subjects not willing to comply to the study protocol
  • Patients with uncontrolled diabetes (HbA1c >7.5)
  • Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate)
  • Periapical lesion in the tested sites

研究组 & 干预措施

recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft

Experimental

recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.

干预措施: growth factors to help in regeneration (Biological)

Enamel matrix derivatives (EMD) in combination with bone allograft.

Active Comparator

Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects.

干预措施: growth factors to help in regeneration (Biological)

结局指标

主要结局

Clinical Attachment Changes

时间窗: 6 months

Change in gingival recession and pocket probing depth

Clinical Attachment Changes

时间窗: 12 months

Change in gingival recession and pocket probing depth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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