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临床试验/CTRI/2020/11/028974
CTRI/2020/11/028974尚未招募不适用

“Evaluation of effectiveness of platelet rich fibrin matrix with demineralized bone allograft in fresh extraction sockets with simultaneous Implant placement.

The Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年11月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
vertical and horizontal crestal bone changes around immediately placed implants.

研究概览

简要总结

BACKGROUND: Implantdentistry has evolved over time with various novel protocols. These protocolshave guided in making the implant placement easier to a point that now theoutcomes can be predicted to a greater extent. Research using biomaterials suchas blood derived membranes and bone grafts have assisted in constant success ofthis therapy. Several strategies includingplacement of immediate implants have been proposed to preserve post extractionalveolar ridge from resorption during healing. The immediate implant treatmentprotocol serves many advantages including minimal surgical interventions, thusreducing total treatment time, preservation of adequate bone height and aestheticoutcomes especially in anterior region.

AIM: This study will be undertaken to evaluate effectiveness of implantplacement immediately followed by tooth removal with simultaneous PRFM andDFDBA grafting using a two-stage protocol.

MATERIAL AND METHODS: Thisstudy will be performed over one year period. Twelve patients, each having onetooth indicated for extraction in the maxilla and/or mandible will be selected.Implants will be placed into fresh extraction socket after augmentation withautologous platelet concentrate and bone graft, using two stage protocol.Second stage study will be performed 5-6 months following implant placement.Abutments will be connected within 3-6 weeks and definitive metal ceramicrestoration will be placed.

EXPECTED RESULTS:The success of the implant will be determined by the crestal bone changes andstability after 6 months following the use of PRFM and Bone graft (DFDBA).

CONCLUSION: Theaugmentation procedures have proved to be effective to achieve bone fill aswell as resolution of bone defects in surrounding implants. Bone augmentationalong with simultaneous implant placement may result in reduction of horizontalbone resorption.

KEYWORDS:Immediate implant, PRFM, DFDBA, Extraction socket, Atraumatic extraction.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Tooth which needs extraction due to root fractures, endodontic failures, internal and external resorption, over-retained deciduous teeth, non-restorable carious lesions, residual roots.
  • 2.Good oral hygiene described as full mouth plaque score of ≤ 25%.
  • 3.Presence of opposing natural tooth.
  • 4.Presence of adjacent teeth.
  • 5.Thick gingival biotype.
  • 6.Radiographic and clinical appearance of intact alveolar bony walls.
  • 7.Presence of ≥4 mm of bone beyond root apex.
  • 8.D-1, D-2 or D-3 bone quality.

排除标准

  • Systemic diseases that compromise bone healing process e.g. (diabetes, bleeding disorders, osteoporosis and allergies to titanium).
  • 2.Severe maxilla-mandibular space discrepancies.
  • 3.Para functional habits like bruxism and/or clenching.
  • 4.Teeth with interdental spacing/ Proclinated teeth/Rotated or mal-aligned anterior teeth.
  • 5.History of alcoholism, excessive smoking or drug abuse.
  • 6.D-4 bone quality.
  • 7.Width of keratinized gingiva less than 2mm at implant site.
  • 9.Untreated dental diseases.
  • 10.Pregnant and lactating mothers.

结局指标

主要结局

vertical and horizontal crestal bone changes around immediately placed implants.

时间窗: 6 months

次要结局

  • implant mobiliy.(baseline, 3 months and 6 months)

研究者

发起方
The Indian Council of Medical Research
申办方类型
Government funding agency

研究点 (1)

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