跳至主要内容
临床试验/CTRI/2025/10/096578
CTRI/2025/10/096578尚未招募Phase 3 4

Volumetric Assessment of Regenerative Efficacy of Demineralized Freeze Dried Bone Allograft with Placental membranes (Amnion membrane and Chorion membrane) in Open Flap Debridement in the Management of Mandibular Degree II Furcation Defects using Cone Beam Computed Tomography with 6 months follow up A Randomized Clinical Trial

Dr Vimarsha R Achar1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Periodontal disease is an inflammatory condition which result in progressive destruction of the periodontium occurs as a result of specific microorganism or groups of microorganisms as the destruction of the periodontium progresses apically, the furcation of multirooted teeth is exposed, leading to the irreversible bone loss in the interradicular area. The management of furcation involvement presents one of the greatest challenges in periodontal therapy, as these defects respond less favourably to the conventional periodontal therapy and lead to the loss of molars than any other tooth type. The treatment of furcation defects represents a great challenge because of their intricate anatomy and variable morphology, which complicates access for proper hygiene, and maintenance. Attempts to treat furcation defects have led to therapies ranging from nonsurgical periodontal therapy, such as scaling and root planing (SRP), to surgical root debridement, root resection, hemi section, regenerative therapy. The most predictable method to treat degree II furcation involvement in mandibular molars and buccal furcation’s in maxillary molars is by regenerative procedures. The ultimate aim of the regenerative procedures is to exclude the epithelium and the gingival corium from the root to delay epithelial down growth during healing and to provide an opportunity for progenitor cells of the periodontal ligament and bone to repopulate previously diseased root surfaces using regenerative materials. Studies have shown that guided tissue regeneration (GTR) can improve the response of advanced grade II furcation defects to therapy by means of pocket depth reduction, gain in clinical attachment levels and bone defect fill DFDBA is thought to be responsible for osteoconductive effect and source of osteoinductive factors because of the presence of “bone morphogenic proteins” The use of demineralized freeze-dried bone allograft (DFDBA) as a bone replacement graft capable of promoting regeneration of the attachment apparatus and has been the focus of much attention throughout the past 30 years and several studies have shown DFDBA as a graft material of greater osteogenic potential when compared to FDBA. Recently amniotic membranes of the developing embryo, that is, amnion (innermost lining) and chorion (a layer next to it), have the properties with significant potential used in dentistry. Placental membranes having their origin from extraembryonic tissue. Amnion is derived from this fetal membrane consists of inner amniotic membrane made up of single layer of amnion cells fixed to collagen rich mesenchyme attached to chorion which is the outermost of the two fetal membranes and is contact with amnion on its inner aspect. Amniotic membrane is a novel tissue engineering biomaterial that has recently been used in the field of dentistry to regenerate lost tissues and accelerate repair. The membrane has numerous growth factors, proteins, and stem cell reserves that help in faster wound healing with regeneration of the lost tissues. The CM membrane has numerous growth factors, proteins, and stem-cell reserves that induce faster wound healing and aid the regeneration of lost tissue. The immuno-privileged human chorion membrane (CM) has antimicrobial and antigenic properties that have been discussed extensively, and it has been recently used for periodontal therapy. Various methods have been adopted for pre- and postsurgical evaluation of the periodontal treatment, including clinical probing, conventional radiographs, surgical re-entry and histologic examination. However, most of these methods failed to evaluate the exact morphology of the periodontal tissues. The advent of cone beam computed tomography (CBCT) enabled clinicians to precisely identify the three-dimensional morphology of the osseous defects along with volumetric assessment of healing periodontal tissues. Effectiveness of the surgical procedure and material used have been assessed in periodontal research by various means, CBCT is one of the non-invasive methods where the volumetric assessment of the bone defect can be done and its application provides significant aid for better understanding of the furcation defects. Thus, aim of present study is to comparative evaluation and volumetric assessment of regenerative efficacy of DFDBA with the placental membranes (amnion and chorion) in open flap debridement in the management of mandibular degree II furcation clinically and radiographically at baseline, 3, 6 months and 6 months follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy male or female patients Moderate to severe chronic periodontitis stage III.
  • Probing pocket depth and clinical attachment level more than 5mm At least one degree II (as per Hamp et al classification) furcation defect on mandibular posteriors Determined by clinical examination and later by radiographic evaluation.

排除标准

  • History of known systemic diseases Allergies Drug use Having undergone surgical periodontal therapy in last 6 months.

结局指标

主要结局

Plaque index

时间窗: baseline | 3 months | 6 months

Gingival index

时间窗: baseline | 3 months | 6 months

Probing pocket depth

时间窗: baseline | 3 months | 6 months

Clinical attachment level

时间窗: baseline | 3 months | 6 months

Horizontal probing depth

时间窗: baseline | 3 months | 6 months

次要结局

  • defect height(defect width)

研究者

发起方
Dr Vimarsha R Achar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vimarsha R Achar

Manipal College Of Dental Sciences, Mangalore

研究点 (1)

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