跳至主要内容
临床试验/NCT07358104
NCT07358104进行中(未招募)不适用

Investigating the Efficacy of Camel Whey Protein and Camel Whey Protein Nanoparticles for Treating Intra-bony Periodontal Defects: Randomized Clinical Trial

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年1月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
1
主要终点
bone fill

研究概览

简要总结

Intraosseous bone defects (IOBDs) are a significant challenge in the treatment of periodontal disease. Several bone graft materials can be used for bone defect regeneration.

Camel whey protein (CWP) has emerged as a promising alternative due to its unique properties, including: High biological value containing essential amino acids, anti-inflammatory, antioxidant and immunomodulatory effects.

However, the therapeutic application of CWP for bone regeneration can be limited by its solubility and bioavailability . Nanoparticles offer a novel approach to enhance drug delivery and improve therapeutic efficacy. Introduction of bone grafts in the form of nanoparticles was found to improve the bioactivity and biocompatibility of artificial bone graft.

Nanoparticles (NPs) can efficiently enter biological organisms due to their very tiny size. The ability of NPs to easily pass through even the smallest blood capillaries and escape being phagocytized due to their small size (1-100 nm) extends their plasma half-life and permits a more progressive release of the medication. Nanoparticles have quicker absorption and a relatively greater drug loading arise from interactions at the surface. NPs increased antibacterial action may be attributed to their huge surface area and high charge density, which allows them to interact with the negatively charged surface of bacterial cells

详细描述

Periodontitis is clinically characterized by loss of gingival tissue attachment to the tooth, deepening of periodontal pocket, degradation of the periodontal ligament, and loss of alveolar bone. This destructive process is associated with the presence of subgingival microbial communities and dense immuno-inflammatory infiltrate in the periodontium that may lead to tooth loss if not appropriately treated.

Periodontitis is associated with a dysbiotic polymicrobial community, in which different members have distinct and synergistic roles that promote destructive inflammation. Inflammation, in turn, can exacerbate dysbiosis through provision of nutrients for the bacteria (derived from tissue breakdown products; eg, collagen peptides and hemecontaining compounds). Therefore, inflammation and dysbiosis are reciprocally reinforced and generate a positive-feedback loop. This self-sustaining loop may underlie the chronicity of periodontitis, the development of which requires a susceptible host.

Risk factors include the presence of bacteria that subvert the host response, systemic disease, smoking, aging and immune deficiencies. These factors could promote dysbiosis by acting individually or, more effectively, in combination.

Periodontal defects have been differentiated based on bone resorption patterns into "supraosseous" ("suprabony") and "infraosseous" ("infrabony") "). Infrabony defects are classified according to the location and number of osseous walls remaining around the pocket. According to the classification by Goldman & Cohen , inrtabony defects are categorized as follows: (i) one-wall intrabony defects: defects bounded by one osseous wall and the tooth surface; (ii) two-wall intrabony defects: defects bounded by two osseous walls and the tooth surface; (iii) three-wall intrabony defects: defects bounded by three osseous walls and the tooth surface.

It has been suggested that the term "intrabony" means "within or inside the bone", while "infrabony" means "below the crest of bone". The authors suggested that only 3-wall angular defects should be termed "intrabony", while all other vertical bony defects should be referred to as "infrabony".

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

participant , investigator and outcome assessors are masked

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The patient age range will be 18-45 years of both sexes Stage III or IV periodontitis (probing depth ≥ 6 mm in teeth and clinical attachment ≥ 5 mm).
  • Clinical and radiographic confirmation of 3 wall intrabony defects.
  • Absence of any complicating systemic condition that may contraindicate surgical procedures.
  • Adequate oral hygiene.
  • Eligible participants should present good general health and agree to random assignment to any of the parallel study groups.

排除标准

  • Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, uncooperative individuals or those unable to attend the study follow-up appointments.

研究组 & 干预措施

Open currettage

Experimental

open flap debridement

干预措施: only open flap debridement (Drug)

Open curettage with scaffold material

Placebo Comparator

scaffold material

干预措施: scaffold material (Drug)

Open curettage with Camel whey protein

Active Comparator

CWP

干预措施: CWP (Drug)

Open curettage with Camel whey protein nanoparticle

Active Comparator

CWP NPs

干预措施: CWP NPs (Drug)

结局指标

主要结局

bone fill

时间窗: 6-months

Radiographic bone fill will be assessed using CBCT by subtracting the preoperative and postoperative x-rays, followed by measuring the resultant bone volume in mm³.

次要结局

  • bone density(6-months)
  • Clinical probing pocket depths(6-months)
  • clinical attachment level(6-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Elamrousy

Professor and postgrad course director of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University

Kafrelsheikh University

研究点 (1)

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