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临床试验/NCT06525324
NCT06525324尚未招募不适用

Comparing The Effectiveness Of T-PRF And PRF With Bone-Graft[DMBM]TM Around Immediate Implants - A RANDOMISED CONTROL TRIAL

Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
2
主要终点
Marginal Bone Level Using RVG and Grid.

研究概览

简要总结

The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.

In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.

So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.

详细描述

Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest.

Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment.

Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination.

The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination.

Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft [DMBM] and PRF with xenograft [DMBM] around immediate implants.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18-55 years of age.
  • Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
  • Good oral hygiene.
  • Good patient compliance.
  • Class I extraction socket defects according to modified Elian et al 2021.

排除标准

  • Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
  • Intravenous and oral bisphosphonate therapy.
  • Patients who are psychologically unable to participate.
  • Pregnant and lactating participants with bone diseases
  • Patients on chemotherapy or radiotherapy
  • Alcohol or drug abuse.

结局指标

主要结局

Marginal Bone Level Using RVG and Grid.

时间窗: Baseline , 3 months , 9 months

Marginal bone level measured .

Bone dimensions using CBCT

时间窗: 9 months

Extent of bone dimensions is measured through CBCT

Bone fill using RVG with grid

时间窗: 3 months , 9 months

Measuring the Bone fill by formula Linear bone growth/depth of original bone defect

Soft tissue healing

时间窗: Baseline ,3 months , 9 months

Soft tissue healing will be assessed using Wachtel-et-al 2009 classification

次要结局

未报告次要终点

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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