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临床试验/CTRI/2024/07/071401
CTRI/2024/07/071401尚未招募不适用

Role of injectable platelet rich fibrin and allograft with amniotic membrane vs probiotic and allograft with amniotic membrane in intrabony defects using nonincised papillae surgical approach- A randomized clinical trial

Panineeya Mahavidyalaya Institute of Dental Sciences and research centre1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年8月6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
22
试验地点
1
主要终点
• Probing pocket depth(PPD)

研究概览

简要总结

•       Periodontitis is a chronic inflammatory disorder, associated with a dysbiotic plaque biofilm, resulting in progressive destruction of the tooth-supporting apparatus and intra bony periodontal defects. Intraosseous defects are a frequent sequelae of periodontitis and when left untreated may significantly affect the long-term success of the affected teeth.   •       Conventional periodontal surgery results in reduction of the pocket depth, elimination of osseous defects but may also be associated with considerable loss of the tooth supporting tissue including the papillae. To overcome these problems along with associated postoperative pain, bleeding, swelling, root hypersensitivity and delayed healing, several minimally invasive and papilla preservation techniques have been employed. The non-incised papilla surgical approach (NIPSA) is one such papilla preservation technique which was developed with the aim of achieving clinical improvements compared with marginal access â€¢       techniques. In NIPSA  an apical approach is carried out, without incisions of tissues at the level of the papillae or marginal tissues, thereby preserving the interproximal tissues which aid in retention of clot in the underlying defect and prevent collapse of marginal tissues. •       Demineralized freeze-dried bone allograft (DFDBA) is osseoinductive and harbours a variety of growth/differentiation factors, bone morphogenetic proteins (BMPs) and is inferred to promote periodontal repair/regeneration, with significant probing pocket depth (PPD)-reduction, clinical attachment level (CAL)-gain and bone fill. It was proposed that mixing I-PRF(injectable platelet rich fibrin) with bone grafts, forming a fibrin-graft-amalgamate , enhanced the graft’s biological properties, handling and stability  •       Injectable platelet-rich fibrin (I-PRF) is the most recent and successful advancement in PRF. It is a liquid autologous platelet concentrate created by low-speed centrifugation concept and omitting the formation of a PRF membrane. It harbours a variety of growth/differentiation factors (GFs),promotes angiogenesis, traps circulating stem cells, induces collagen synthesis, and stimulates the growth of fibroblasts and osteoblasts as well as the prolonged delivery of growth factors to the area where a wound is present.     Probiotics are live cultures of microorganisms that confer a health benefit by exerting a biological response in the host when administered in adequate amounts. They have been proposed for  as a possible alternative to standard antimicrobial adjuvants in periodontitis where scaling and root planing therapy alone is not successful.  It is suggested that they are able to induce changes in the structure of the bacterial community, which could lead to changes in interbacterial interactions, decrease the virulent periodontopathogens, modulate the immune  response of the host and restore the balance of the oral ecosystem .  •       Amniotic membrane serves as a fibrillar scaffold and  serves as a reservoir of stem cells, modulates angiogenesis and promote wound healing .The presence of the non-collagenous proteins in the amniotic membrane makes it superior to the collagen membrane as these proteins serve to modulate the cell behaviour in wound healing. It has been suggested combining the use of bone grafts with the barrier membrane to obtain a synergistic effect termed as Combined Periodontal Regenerative Therapy (CPRT ).

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • • Patients aged ≥ 20 years with Stage III periodontitis • Patient having at least one tooth with intra bony defect ≥3mm {two wall or combined two to three walled intraosseous defect} (assessed by trans-gingival probing, radiographic examination) • CAL≥ 5mm • PD ≥6 mm.

排除标准

  • • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • • Smokers • Pregnant and lactating mothers • History of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • • Surgical periodontal therapy carried out in the past 6 months.

结局指标

主要结局

• Probing pocket depth(PPD)

时间窗: Baseline and 6 months

• Clinical Attachment level(CAL)

时间窗: Baseline and 6 months

• Bone fill assessed by CBCT

时间窗: Baseline and 6 months

次要结局

  • • Recession depth (RD)(• Location of the tip of the papilla (LTP))

研究者

发起方
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrKRekha Rani

Panineeya Mahavidyalaya Institute of dental sciences and research centre

研究点 (1)

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