Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prosthesis Supported by Zantex or Zirconia Framework. A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Complete edentulism remains a major clinical challenge, particularly among aging populations. All-on-Four fixed implant-supported prostheses have become a widely used solution, but the long-term success of these restorations depends heavily on the framework material used, including its resistance to microbial adhesion and its effect on peri-implant tissue health.
This randomized clinical trial compares two framework materials: Zirconia, a high-strength ceramic material, and Zantex, a fiber-reinforced polymer material, both used to fabricate mandibular hybrid prostheses supported by four implants placed following the All-on-Four protocol.
Microbial adhesion will be assessed by evaluating biofilm accumulation on the prosthesis frameworks retrieved under sterile conditions at set time intervals. Peri-implant tissue health will be evaluated clinically at 1 week, 2 weeks, 1 month, and 3 months following prosthesis delivery, using standard clinical parameters including modified plaque index, modified bleeding on probing, and probing depth.
A total of 14 patients (7 per group) will be enrolled based on sample size calculations targeting 90% statistical power.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egipto, 33511
- Reclutamiento
- Faculty of Dentistry, Kafrelsheikh University
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Contacto:
- Maged Alameri, BDS
- Número de teléfono: 00201155617217 00201117599298
- Correo electrónico: majed.alameri.07@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Completely edentulous patients in the mandibular arch.
- Patients with a completely edentulous maxillary arch rehabilitated with a conventional complete denture.
- Patients with sufficient mandibular bone volume and quality to allow placement of four implants according to the All-on-Four treatment concept.
- Patients suitable for placement of two axial anterior implants in the canine regions and two distally tilted posterior implants anterior to the mental foramina.
- Patients with adequate restorative space to accommodate a full-arch hybrid prosthesis.
- Patients who are willing and able to maintain adequate oral hygiene and attend all scheduled follow-up appointments.
Patients who are willing to participate in the study and sign the informed consent form.
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Exclusion Criteria:
1. Patients with systemic conditions that contraindicate implant surgery or may adversely affect osseointegration or wound healing.
2. Patients receiving medications or undergoing treatments that significantly affect bone metabolism or healing.
3. Patients with a history of radiotherapy involving the head and neck region that may compromise implant therapy.
4. Patients with active or uncontrolled periodontal or oral infections. 5. Patients with inadequate mandibular bone volume or unfavorable anatomical conditions that prevent placement of four implants according to the planned All-on-Four protocol without additional augmentation procedures.
6. Patients with severe parafunctional habits, such as uncontrolled bruxism, that may compromise the prosthetic rehabilitation.
7. Patients unable or unwilling to maintain appropriate oral hygiene. 8. Patients unable to attend the scheduled follow-up visits. 9. Patients who decline to participate or fail to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Zirconia Framework Group
Mandibular hybrid prosthesis fabricated with Zirconia framework, supported by four implants following the All-on-Four protocol.
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A metal-free zirconia ceramic framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol)
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Experimental: Zantex Framework Group
Mandibular hybrid prosthesis fabricated with Zantex (fiber-reinforced polymer) framework, supported by four implants following the All-on-Four protocol.
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A fiber-reinforced polymer (Zantex) metal-free framework used to fabricate a screw-retained mandibular hybrid prosthesis supported by four dental implants (All-on-Four protocol).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Microbial Adhesion on Prosthesis Framework
Periodo de tiempo: At 1 week, 1 month, and 3 months after prosthesis delivery
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Quantitative assessment of bacterial biofilm accumulation on the intaglio surface of the prosthesis framework, measured using microbiological culture/colony counting techniques.
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At 1 week, 1 month, and 3 months after prosthesis delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Modified Plaque Index
Periodo de tiempo: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Plaque Index (mPI) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater plaque accumulation (worse outcome).
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Bleeding on Probing Index (mBOP)
Periodo de tiempo: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Modified Bleeding on Probing (mBOP) assessed using a standardized plastic periodontal probe at multiple sites around each implant, scored on a scale from 0 to 3, where higher scores indicate greater bleeding tendency (worse outcome).
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Probing Depth
Periodo de tiempo: At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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At 1 week, 2 weeks, 1 month, and 3 months after prosthesis delivery
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KFSIRB200-722
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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