跳至主要内容
临床试验/CTRI/2015/08/006100
CTRI/2015/08/006100已完成2/3 期

Comparative evaluation of socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement– A Clinico-Radiographic Study.

Sinhgad Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年3月2日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Clinical and Radiographic of

研究概览

简要总结

After extraction, severe hard and softtissue alteration takes place within the affected site of alveolar ridge.1The three dimensional resorption process at extraction sites results innarrower ridges and reduced vertical height and lingual/palatal shifting oftheir long axis. Most of the dimensional alterations take place in the first 3months following tooth removal.2

In the first 12 months after extraction,the height of alveolar ridge can diminish upto 50% because the alveolar boneresorbs especially on the buccal aspect.3  This change may lead to esthetic andfunctional disadvantages that compromise future implant placement particularlyif the dental implant placement needs to be delayed for 6 months or longer.

 Hence it is crucial to preserve the dimensions andcontour of the alveolar ridge after tooth extraction to achieve a predictableesthetic and functional prosthetic restoration.

Preservation of the residual alveolarsocket at the time of tooth extraction has been evaluated in many studies.  Clinical, histologic and radiographic studiesdocumented positive socket healing responses with autogenous bone, alloplastsand xenografts, whereas others reported poor results with bovine bone,decalcified freeze dried bone & autogenous bone.1, 4, 5, 6, 7, 8

 Since they are associated with varyingamounts of vital bone socket fill, comparison studies are useful to determinethe amount of socket preservation that occurs with each material. A new classof alloplast materials, namely, calcium phosphate cements (CPC) raised certainhopes in periodontal repair in the early 1990s. These are aqueous based cements that get converted to hydroxyapatiteupon setting.  The combination of biocompatibility,osteoconductivity and restorability makes it a unique material for graftingbony defects.9

 Platelet rich fibrin (PRF) is anautologous preparation of concentrated platelets created by centrifugation of apatient’s blood.  The use of PRF duringsurgical procedure is a current treatment concept used to accelerate woundhealing and tissue maturation.  It can beused directly as a clot or after compression as a strong membrane. 10

 Based on these positive findings of calciumphosphate cement and platelet rich fibrin, the purpose of this study is tocompare clinical and radiographic [Cone Beam Computed Tomography (CBCT)]outcomes following grafting for post extraction ridge preservation in sitestreated with platelet rich fibrin with or without calcium phosphate cement.

Aim:

To compare the use of platelet richfibrin (PRF) with and without calcium phosphate cement in fresh extractionsockets by clinical and radiographic analyses.

 Objectives:

1.  Toevaluate horizontal and vertical ridge changes associated with PRF used withand without CPC at baseline and after 6 months using clinical and radiographic methods.

2.  Tocompare horizontal and vertical ridge changes associated with PRF used with andwithout CPC using clinical and radiographic methods.

3.  Toevaluate and compare the radiographic density changes associated with PRF usedwith and without CPC.

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 Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients between the age group 20- 45 years Patients having at least two non-molar teeth indicated for extraction.
  • Indications for extraction include either root fracture, endodontic treatment failure, or non-restorable carious teeth.
  • Alveolar sockets with 4 wall architecture.
  • Patients willing to participate and sign an informed consent.

排除标准

  • Patients who are systemically compromised.
  • Patients having history of smoking or tobacco habit.
  • Patients on medications that impair hematological parameter.
  • Patient having history of bone disorder.
  • Teeth having acute periapical or periodontal pathology.
  • Pregnant and lactating females.

结局指标

主要结局

Clinical and Radiographic of

时间窗: Time point-at 6 months

a.Marginal bone levels, calculated using a Williams periodontal probe as the distances between the coronal border of the stent and the mid-buccal and the mid-palatal aspect of the alveolar bone crest.

时间窗: Time point-at 6 months

b.The bucco-palatal width will be measured using a surgical caliper at mid-buccal and mid-palatal aspect of the socket at 1mm, 3mm and 5mm apical to the bone crest.

时间窗: Time point-at 6 months

Time point-at 6 months

时间窗: Time point-at 6 months

次要结局

未报告次要终点

研究者

申办方类型
Private medical college

研究点 (1)

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