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临床试验/CTRI/2025/07/091854
CTRI/2025/07/091854尚未招募3 期

Efectiveness of xenograf and injectable PRF (I-PRF) Compared to Xenograft, and unassisted healing for Socket Preservatlon in Adults U ndergoing Tooth Extraction

Dr Prameetha George Ittycheria1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Clinically horizontal ridge width(buccolingual and mesiodistal) and vertical (mid-buccal, mid-lingual, mesial, and distal) ridge height.2 Using CBCT , (1) the mean width difference between the outer borders of the buccal and lingual cortical plates at 1, 3, and 5 mm socket depths, (2) the mean width of the buccal plate at the same depths.3.Histomorphometric analysis of the percentage of vital bone

研究概览

简要总结

Tooth extraction often leads to alveolar bone resorption, negatively affecting future prosthetic or implant rehabilitation. Socket preservation techniques have been introduced to minimize post-extraction bone loss, with biomaterials such as xenografts commonly used to maintain bone volume. Though graft materials can reduce alveolar bone resorption, grafted sites often have poor vascularization and nonvital residual particles which can negatively affect the bone to implant contact. A combination of autologous platelet concentrates with the graft which will  improve the percentage of new bone formation Recently, injectable platelet rich fibrin has gained attention for its potential to enhance wound healing and bone regeneration due to its sustained release of growth factors. However, research on the combined use of injectable platelet-rich fibrin and xenografts for socket preservation remains limited. This study evaluates the clinical, radiographic, and histological outcomes of socket preservation using injectable platelet-rich fibrin , xenograft, and a resorbable membrane, compared to xenograft with a resorbable membrane and unassisted healing. Clinical parameters, including the gingival index and wound healing index, will be evaluated. Vertical and horizontal ridge width measurements will also be assessed using a digital caliper. Additionally, radiographic measurements using CBCT imaging will be performed to evaluate horizontal and vertical ridge dimensions, buccal plate thickness, and bone density. Histologic analysis after six months will assess new vital bone formation, connective tissue, and residual bone graft. Sample size calculated using the mean and SD of the loss of ridge height in the three groups from previous study ,is 15 per group . Patients will be randomly assigned to one of three groups using a permuted block randomization fixed  method and allocation concealment by sequentially numbered sealed opaque envelops. Group 1 will receive socket preservation with xenograft, membrane, and injectable platelet-rich fibrin. Group 2 will receive xenograft and membrane  and  the control group will undergo unassisted healing. Clinical and radiographic parameters will be recorded after 6 months and the outcome assessor will be blinded. This comprehensive evaluation aims to determine the effectiveness of socket preservation using injectable platelet-rich fibrin and xenograft in maintaining ridge dimensions and increase in amount of vital bone and reduction in residual graft material there by promoting bone regeneration for future implant placement.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Maxillary and mandibular single rooted teeth requiring extraction .
  • Type 1,Type 2 extraction socket (Endodontic origin, fracture, severe caries, Periodontal origin, periodontal-endodontic combined )
  • more than or equal to 18 years of age
  • Patients with no systemic diseases.

排除标准

  • Uncontrolled diabetes
  • Smokers (more than or equal to10 cigarettes/day)
  • Use of immunosuppressing medication
  • Use of anticoagulants
  • Pregnant women
  • Patients with Stage III or IV periodontal disease Grade C.

结局指标

主要结局

Clinically horizontal ridge width(buccolingual and mesiodistal) and vertical (mid-buccal, mid-lingual, mesial, and distal) ridge height.2 Using CBCT , (1) the mean width difference between the outer borders of the buccal and lingual cortical plates at 1, 3, and 5 mm socket depths, (2) the mean width of the buccal plate at the same depths.3.Histomorphometric analysis of the percentage of vital bone

时间窗: Clinical and radiographic meaurements at baseline and at 6 months | Histomorphometric analysis at 6months

次要结局

  • Healing Index(socket length)

研究者

发起方
Dr Prameetha George Ittycheria
申办方类型
Other []
责任方
Principal Investigator
主要研究者

PRAMEETHA GEORGE ITTYCHERIA

Pushpagiri college of dental sciences

研究点 (1)

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