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临床试验/CTRI/2022/05/042789
CTRI/2022/05/042789进行中(未招募)不适用

Evaluation of stability, soft tissue and hard tissue changes in implants placed with and without application of hyaluronic acid gel

Balla sowmya1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年5月25日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
28
试验地点
1
主要终点
To evaluate and compare Resonant frequency analysis (RFA) and crestal bone level (CBL) between groups

研究概览

简要总结

Replacement of missing teeth with an implant in partially or fullyedentulous sites has become a preferred and realistic alternative treatmentwithout involving adjacent teeth. Single tooth replacement with endosseousdental implant comprises the most widely used form with success rates of 90% to100% in terms of implant survival and prosthetic outcomes. Implantrehabilitation of missing tooth has been most widely opted treatment modalityfor partially/completely edentulous patients who aspire long term survival andsuccess rates of the replaced prosthesis. However, implant success is mostlydependent on the concept of “OSSEOINTEGRATION†proposed by Branemark inthe year 1969, which nearly takes 6 to 7 months to heal without anyintervention. Osseointegration refers to a direct structural and functionalconnection between ordered, living bone and the surface of a load-carryingimplant. Currently, an implant is considered as osseointegratedwhen there is no progressive relative movement between the implant and the bonewith which it has direct contact. Differentapproaches have been introduced lately to positively enhance the healing arounddental implants. One approach to enhance osseointegration of dental implants isthe coating with organic components of the extracellular matrix. Hyaluronicacid (HA) was First discovered in the vitreous humour ofthe eye in 1934 and subsequently synthesized in vitro in 1964, hyaluronic acid(or hyaluronate or hyaluronan) is a negatively charged, with high molecularweight (up to 107 Daltons) glycosaminoglycan found predominantly in theextracellular matrix. Hyaluronic acid possesses physiologicaland structural functions in the tissues, including cellular and extracellularinteractions, interactions with growth factors and regulation of the osmoticpressure and tissue lubrication, which helps in maintaining the tissuesstructural and homeostatic integrity. Hyaluronicacid has a multifunctional role in healing chronic lesions, including thosethat are observed in periodontal disease. HA-coatedsurface may possess a higher potency to enhance osteogenesis. This study is designed to  evaluate the efficacy of hyaluronic acid gelon implant stability, soft tissue and hard tissue changes when compared toconventional implant placement

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Individuals in need of tooth replacement.
  • Presence of adequate keratinized mucosa in the edentulous site.
  • Apparently healthy individuals.
  • 4.Individuals with adequate bone volume with D2 and D3 type of bone.
  • Patient who are willing to give informed consent.

排除标准

  • Individuals with parafunctional habits.
  • Pregnant and lactating women.
  • Patients taking any medication or drug that could jeopardize treatment outcome.

结局指标

主要结局

To evaluate and compare Resonant frequency analysis (RFA) and crestal bone level (CBL) between groups

时间窗: baseline ,3months and 6 months

次要结局

  • To evaluate and compare plaque index(PI), gingival index(GI), Width of the keratinized tissue (WKT), Thickness of keratinized tissue (TKT)

研究者

发起方
Balla sowmya
申办方类型
Other [sibar institute of dental sciences]

研究点 (1)

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