Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
25 de abril de 2026 actualizado por: Caroline John George, Cairo University
Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae?
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
This study aims to assess whether the buccal fat pad might prevent mucosal dehiscence and avoid potential postoperative complications when buccal fat pad is used to cover the body part of the zygomatic implants compared to the platelet rich fibrin during the reconstruction of atrophic maxilla.
The expected benefit from the current study is to select the most suitable coverage for Zygomatic implant placement with the least postoperative complications also providing an appropriate soft tissue profile during the immediate loading phase preparing it for the final restoration.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
24
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.
Estudio Contacto
- Nombre: Caroline John Caroline John George, masters
- Número de teléfono: +201282101184
- Correo electrónico: caroline.john@dentistry.cu.edu.eg
Ubicaciones de estudio
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Cairo Governorate
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Cairo, Cairo Governorate, Egipto, 11562
- Reclutamiento
- Cairo university, Faculty of dentistry
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Contacto:
- Número de teléfono: 01223617956
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
- Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
- Lacking posterior maxillary bone support due to significant sinus pneumatization
- Good systemic health (ASA score I-II)
- Highly motivated patients
Exclusion Criteria:
- Patient not willing to give his/her informed consent.
- Patients with systemic disease that did not permit the surgical procedure (including general anesthesia).
- Patients with uncontrolled diabetes or under bisphosphonate therapy.
- Heavy smoker. (> 20 cigarettes daily)
- Patient with psychiatric problems, severe bruxism or other parafunctional habits.
- Acute sinusitis.
- Malignancy or pathology in Maxilla or Zygoma.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Coverage with PRF for Zygomatic implant placed
PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared.
Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation.
The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm.
The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation
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PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared.
Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation.
The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm.
The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation
|
|
Comparador activo: Coverage with buccal fat pad for Zygomatic implant placed
Broad muco-periosteal dissection of the anterior maxilla and its lateral sides can easily be used to make an incision of the periosteum in the area of the wisdom teeth during implant insertion. The buccal fat pad will be dissected into the oral cavity after being enlarged with scissors. The pad can be moved forward and lower to cover the implants by gently pulling it with an atraumatic clamp. Resorbable sutures are then used to secure it to the palatal mucosa, The flap will be repositioned over the BPF and sutured to the palatine mucosa. The posterior implant typically has the easiest time achieving implant coverage. To prevent premature traction, the dissection must be done very carefully. The pad must be gradually released from its capsule in order to complete the task. It is not problematic if there are pieces of the fat pad along the crestal suture. After surgery, this will turn into the epidermis in a few days. The buccal fat pad going to be repositioned over implant body |
PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared.
Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation.
The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm.
The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The peri-implant soft tissue thickness
Periodo de tiempo: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.
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The peri-implant soft tissue thickness using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe (HH12 periodontal probe, Deppeler SA)
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Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative complications
Periodo de tiempo: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.
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Recording of frequency and Incidence of Zygomatic fracture/oroantral communication/implant failure
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Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Blanco-Ruiz S, Molinero-Mourelle P, Blanco-Ruiz M, Fernandez-Tresguerres FG, Blanco-Samper S, Lopez-Quiles J. Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study. Med Oral Patol Oral Cir Bucal. 2023 Jul 1;28(4):e371-e377. doi: 10.4317/medoral.25792.
- Lima VCDS, Miguel MMV, Ferraz LFF, Filho ABM, Jardini MAN, Santamaria MP. Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series Study. Clin Adv Periodontics. 2022 Mar;12(1):17-20. doi: 10.1002/cap.10143. Epub 2021 Jan 12.
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)
1 de diciembre de 2025
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de abril de 2026
Última verificación
1 de diciembre de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 29425
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
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