- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07358104
Eficácia da Proteína de Soro de Camelo e das Nanopartículas de Proteína de Soro de Camelo no Tratamento de Defeitos Periodontais Intraósseos
Investigação da Eficácia da Proteína de Soro de Camelo e das Nanopartículas de Proteína de Soro de Camelo no Tratamento de Defeitos Periodontais Intra-ósseos: Ensaio Clínico Randomizado
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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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".
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Egito, 214312
- faculty of dentistry, kafrelsheikh University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Allergy
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Open currettage
open flap debridement |
only open flap granulation tissue debridement |
|
Comparador de Placebo: Open curettage with scaffold material
scaffold material |
open flap debridement with defect filling with scaffold material |
|
Comparador Ativo: Open curettage with Camel whey protein
CWP |
open flap debridement with defect filling with CWP |
|
Comparador Ativo: Open curettage with Camel whey protein nanoparticle
CWP NPs |
open flap debridement with defect filling with CWP NPs |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
bone fill
Prazo: 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. |
6-months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
bone density
Prazo: 6-months
|
radiogeaphic bone density will be assessed using CBCT |
6-months
|
|
Clinical probing pocket depths
Prazo: 6-months
|
Clinical probing pocket depths will be measured in mm from gingival margin to the base of the sulcus using graduated periodontal probe |
6-months
|
|
clinical attachment level
Prazo: 6-months
|
clinical attachment level will be measured in mm from cementoenamel junction to the base of the sulcus using graduated periodontal probe |
6-months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KFSIRB200-317
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
undecided
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