- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07589426
Horizontal Ridge Augmentation in Maxillary Esthetic Zone Using Bovine Bone Graft Versus Extended Sticky Bone With Simultaneous Implant Placement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patient selection This study will involve sixteen implants inserted in patients with missing upper tooth / teeth in the esthetic zone accompanied by horizontal alveolar ridge resorption, seeking future tooth replacement. The patients will be selected from the Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University
Inclusion Criteria:
- Patient aged 18-45 years.
- Cooperative patient with high motivation and acceptable oral hygiene.
- Maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification). (22)
- No deep undercut at the ridge in the buccal aspect.
- The presence of enough keratinized gingiva(≥3mm).(23)
- Sufficient inter-arch space to accommodate the future prosthesis. (24)
- Patients able to comply with the required recall visits.
Exclusion criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery
- Smokers
- Pregnancy.
- Parafunctional habits, including bruxism and clenching.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Al Mansurah, Egipto
- Mansoura University
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Al Mansurah, Egipto
- Amira Attia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patient aged 18-45 years, Cooperative patient with high motivation and acceptable oral hygiene, maxillary narrow ridge in the esthetic zone that needed horizontal bone augmentation. (Class I Siebert classification) (24),No deep undercut at the ridge in the buccal aspect, The presence of enough keratinized gingiva(≥3mm).(25), sufficient inter-arch space to accommodate the future prosthesis. (26) , and Patients able to comply with the required recall visits.
Exclusion Criteria:
- Local and / or systemic conditions that contraindicate the placement of dental implant or surgery, smokers, pregnancy and parafunctional habits, including bruxism and clenching.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using Medpark
For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site.
For group II, extended sticky bone (ESB) was prepared by centrifugation of autologous blood followed by preparation of ALB-PRF and mixing with bone particulates (50:50 allograft: xenograft) to obtain the final graft materia
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The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
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Experimental: Eight dental implants were inserted simultaneously with horizontal ridge augmentation using extended
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The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b The oral cavity was prepared using 0.12% chlorhexidine mouth rinse for one minute. Local anesthesia was administered using articaine 4% with 1:100,000 epinephrine. A full-thickness mucoperiosteal flap was reflected using a crestal horizontal incision with vertical releasing incisions to expose the surgical site. Osteotomy preparation was performed using a pilot drill to the planned depth at 800-850 rpm under copious sterile saline irrigation, followed by sequential drilling according to the manufacturer's protocol until the final implant size was achieved. The sterile implant was then inserted using a ratchet wrench. (Fig.1B & Fig.2B) Implant stability was immediately assessed using resonance frequency analysis (Osstell device), and cover screws were subsequently placed. For group I, Medpark bone graft was prepared by hydration with sterile saline, gentle mixing, and allowed to partially set before application to the defect site. For group II, extended sticky bone (ESB) was prepared b |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implant Stability Quotient (ISQ) Values Assessed by Resonance Frequency Analysis
Periodo de tiempo: Baseline and 6 months after implant placement
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Implant stability was assessed using resonance frequency analysis (RFA) with the Osstell device and expressed as Implant Stability Quotient (ISQ) values. ISQ scores range from 1 to 100, with higher scores indicating greater implant stability and osseointegration. High stability: ISQ > 70 Medium stability: ISQ 60-69 Low stability: ISQ < 60 Measurements were recorded immediately after implant placement and at the 6-month follow-up. |
Baseline and 6 months after implant placement
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Ms.25.04.21
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.
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