the Effect of Topical Application of Hyaluronic Acid on Immediate Dental Implant

赞助:

合作者:

信息的提供 (责任方):

Ibrahim samy kalboush，Cairo University

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

October 20, 2018

预计主要完成日期

August 30, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

implant stability[ Time Frame: 6 months ]

implant stability using osstel "implant stability quotient (ISQ)"

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

soft tissue healing[ Time Frame: 10 days ]
assessment of soft tissue healing using likert scale from (0-4) with 0: Complete wound closure without presence of fibrin and 4:Incomplete wound closure (necrosis).
post operative pain[ Time Frame: 7 ays ]
assessment of pain severity with 10 point visual analogue scale (VAS) no pain '0' to severe/unbearable pain '10'

描述性信息

简略标题 ^ICMJE

the Effect of Topical Application of Hyaluronic Acid on Immediate Dental Implant

正式标题 ^ICMJE

The Effect of Hyaluronic Acid on Implant Stability After Immediate Implant Placement in Anterior and Premolar Region in Systemically Healthy Patients

简要概况

The high predictability of immediate dental implants has led to routine use with a great expectation for success. Immediate implant placement in fresh extraction sockets was reported to reduce alveolar bone resorption, Better esthetic outcomes were achieved including the prosthetic crown length in harmony with the adjacent teeth, natural scalloping and easier distinct papillae to achieve and maximum soft tissue support. hyaluronic acid can be placed in freshly extracted sockets immediately after tooth extraction , also it could be used on implant surface in which hyaluronic acid enhance new bone formation around dental implants.

详细说明

Immediate dental implant placement was introduced more than 30 years ago by Schulte and Heimke in 1976. The major advantages of immediate implant placement are reduction in number of visits, thus reduces the treatment time and improves patient satisfaction, provides ideal three dimensional implant position, and preserves the alveolar bone in the extraction socket . However, immediate implants may have some disadvantages that can affect the success rate, which include inadequate primary implant stability when compared with delayed implants, inadequate soft tissue closure especially in case of thin tissue biotype, inability to inspect all aspects of the extraction site for defects or infection, and finally the added cost of bone grafting when the jumping distance is over 2mm. Hyaluronic acid (HA) is one of the extracellular components of the connective tissue that belongs to the family of glycosaminoglycans, due to its non-immunogenic and non-toxic properties , it can be used in many medical fields such as dentistry, ophthalmology, dermatology. HA has an important role in wound healing through inducing early granulation tissue formation, inhibiting destructive inﬂammatory process during the process of tissue healing, inducing re-epithelialization and angiogenesis. HA not only acted as a carrier of growth factors and cells but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts. Although HA shares bone induction properties with osteogenic growth factors as bone morphogenic protein 2 and osteopontin. HA also has anti-inflammatory effect through scavenging reactive oxygen species, such as superoxide radical (O2) and hydroxyl radical (OH) species, and inhibiting neutrophil derived serine proteinases, HA also has anti-edematous effect that may be related to its osmotic buffering capacity. So surrounding of an implant with hyaluronic acid give a great potential to improve new bone formation and improve bone/implant contact which will improve healing time and implant stability.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: randomized clinical trial
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: immediate dental implant
immediate dental implant placement in freshly extracted socket.
Drug: Hyaluronic Acid
topical application of hyaluronic acid

研究工具

Experimental: immediate implant with hyaluronic acid.
immediate dental implant with topical application of hyaluronic acid.
Active Comparator: immediate implant.
immediate dental implant placement.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 15, 2022

预计主要完成日期

August 30, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Systemically healthy patients indicated for single or multiple immediate implants in anterior and premolar region. Absence of any peri-apical pathosis. Patients with intact buccal plate of bone. Patients with adequate bone volume for the dental implant procedure. Patient consent approval and signing. Exclusion Criteria: - Smokers. Systemic disease that may affect the final outcome of the surgical procedure. No or poor patient's compliance. Patients with psychological problems. Pathology at the site of intervention. Pregnant patients. Patients refuse to sign an informed consent.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：60 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Ibrahim samy kalboush，Cairo University

研究赞助商 ^ICMJE

Ibrahim samy kalboush

合作者 ^ICMJE

研究员 ^ICMJE

Study Chair: Mona shoeib, Doctor's Cairo University
Study Chair: Mona Darhous, Doctor's Cairo University
Study Chair: Enji Ahmed, Doctor's Cairo University

PRS 账户

Cairo University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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