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Eficacia de la Proteína de Suero de Camello y las Nanopartículas de Proteína de Suero de Camello para el Tratamiento de Defectos Periodontales Intraóseos

3 de noviembre de 2026 actualizado por: Walid Elamrousy, Kafrelsheikh University

Investigación sobre la Eficacia de la Proteína de Suero de Camello y las Nanopartículas de Proteína de Suero de Camello para el Tratamiento de Defectos Periodontales Intraóseos: Ensayo Clínico Aleatorizado

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

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

44

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Kafrelsheikh
      • Kafr ash Shaykh, Kafrelsheikh, Egipto, 214312
        • faculty of dentistry, kafrelsheikh University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 45 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Open currettage

open flap debridement

only open flap granulation tissue debridement

Comparador de placebos: Open curettage with scaffold material

scaffold material

open flap debridement with defect filling with scaffold material

Comparador activo: Open curettage with Camel whey protein

CWP

open flap debridement with defect filling with CWP

Comparador activo: Open curettage with Camel whey protein nanoparticle

CWP NPs

open flap debridement with defect filling with CWP NPs

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
bone fill
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
bone density
Periodo de tiempo: 6-months

radiogeaphic bone density will be assessed using CBCT

6-months
Clinical probing pocket depths
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de enero de 2026

Finalización primaria (Actual)

24 de agosto de 2026

Finalización del estudio (Actual)

14 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

2 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2026

Publicado por primera vez (Actual)

22 de enero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • KFSIRB200-317

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

undecided

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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