Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone
12 de junio de 2026 actualizado por: Gulf Medical University
Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone. A Randomized Clinical Trial
An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants.
The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant.
While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13,
14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14.
PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants.
The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant.
While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.7,
8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors.
Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration.
Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
26
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: Nesma Shemais, PhD
- Número de teléfono: 0529961988
- Correo electrónico: dr.nesma@gmu.ac.ae
Ubicaciones de estudio
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, Emiratos Árabes Unidos, 00000
- Reclutamiento
- Gulf Medical University
-
Contacto:
- Nesma Shemais
- Número de teléfono: 0529961988
- Correo electrónico: dr.nesma@gmu.ac.ae
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of < 25%) and with stable periodontal status.
-Exclusion Criteria: Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance.
Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
|
Comparador activo: Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti
The test group will be treated with dental implant + multilayered PRF membrane.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
The test group will be treated with dental implant and CTG.
In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site.
A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone.
The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position.
For the purposes of standardization, implants will be placed at subcrestal level in both the groups.
In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment.
Simple interrupted sutures will be used to approximate the tissues.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peri-implant soft tissue thickness
Periodo de tiempo: Time Frame: 6 weeks and 3 and 6 months
|
Volumetric
|
Time Frame: 6 weeks and 3 and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
width of the keratinized tissue around dental implants
Periodo de tiempo: Time Frame: baseline, 3 and 6 months
|
Periodontal probe mm
|
Time Frame: baseline, 3 and 6 months
|
|
Marginal bone loss
Periodo de tiempo: 6 months
|
CBCT measurement
|
6 months
|
|
Postoperative patient satisfaction VAS 0-5
Periodo de tiempo: baseline, 2 weeks, 6 months
|
VAS 0-5
|
baseline, 2 weeks, 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Nesma MF Shemais, Assistant professor of Periodontology
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)
10 de enero de 2026
Finalización primaria (Estimado)
10 de enero de 2027
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZainabMDSperio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .