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Titanium-prepared Platelet-rich Fibrin for Treatment of Gingival Recession Using the VISTA Technique

9 de mayo de 2026 actualizado por: Arab International University

Titanium-prepared Platelet-rich Fibrin Versus Connective Tissue Graft in Gingival Recession Treatment: a Split-mouth Randomized Clinical Trial

This split-mouth randomized clinical trial aims to compare the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) and connective tissue graft (CTG) in the treatment of Miller Class I and II gingival recession using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with bilateral gingival recession defects will receive both interventions, with one side randomly assigned to T-PRF and the contralateral side assigned to CTG. Clinical outcomes including recession depth, attached gingival width, probing depth, relative attachment level, healing, and patient satisfaction will be evaluated over a 6-month follow-up period.

Descripción general del estudio

Descripción detallada

Gingival recession is a common periodontal condition characterized by apical displacement of the gingival margin, resulting in root exposure, dentin hypersensitivity, esthetic concerns, and increased susceptibility to root caries. Connective tissue grafts (CTG) are widely considered the gold standard for root coverage procedures due to their predictable clinical outcomes. However, CTG requires harvesting tissue from a secondary surgical donor site, which may increase postoperative discomfort and patient morbidity.

Titanium-prepared platelet-rich fibrin (T-PRF) is a second-generation autologous platelet concentrate prepared using titanium tubes, which may enhance fibrin network quality and improve soft tissue healing and regeneration. T-PRF has been proposed as a less invasive alternative to CTG in periodontal plastic surgery.

The present study is designed as a split-mouth randomized controlled clinical trial to compare T-PRF and CTG in the treatment of bilateral Miller Class I and II gingival recession defects using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique. Twenty systemically healthy adult participants with symmetrical gingival recession defects will be enrolled. Each participant will receive both interventions: one side of the mouth will be randomly assigned to treatment with VISTA combined with CTG, while the contralateral side will receive VISTA combined with T-PRF.

Randomization will be performed using a computer-generated allocation sequence prepared by an independent investigator. Due to the nature of the interventions, operator blinding is not feasible; however, all clinical measurements and outcome assessments will be conducted by a blinded examiner.

Clinical parameters including gingival recession depth, attached gingival width, probing depth, and relative attachment level will be measured at baseline, 3 months, and 6 months postoperatively using a UNC-15 periodontal probe. Early wound healing will be assessed at 1, 2, and 4 weeks using a healing index. Patient-reported satisfaction and postoperative outcomes will be evaluated using a visual analog scale (VAS).

The study aims to determine whether T-PRF can provide comparable clinical and patient-centered outcomes to CTG while reducing the morbidity associated with donor site harvesting.

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

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

      • Damascus, Siria
        • School of Dental Medicine

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

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Systemically healthy
  2. Bilateral gingival recession
  3. Good oral hygiene

Exclusion Criteria:

  1. Smokers
  2. Pregnant/lactating women
  3. Systemic diseases affecting healing
  4. Previous surgery

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 cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: VISTA + Titanium-Prepared Platelet-Rich Fibrin (T-PRF)
Sites allocated to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled gingival tissue.
The gingival recession defects assigned to the test group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with titanium-prepared platelet-rich fibrin (T-PRF). T-PRF membranes will be prepared from the participant's autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol before placement beneath the tunneled flap.
Comparador activo: VISTA + Connective Tissue Graft (CTG)
Sites allocated to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique in combination with an autogenous connective tissue graft (CTG) harvested from the palatal donor site and placed beneath the tunneled gingival tissue for root coverage.
The gingival recession defects assigned to the control group will be treated using the Vertical Incision Subperiosteal Tunnel Access (VISTA) technique combined with an autogenous connective tissue graft (CTG). The graft will be harvested from the palatal donor site and positioned beneath the tunneled gingival tissue to achieve root coverage and soft tissue augmentation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gingival Recession Depth
Periodo de tiempo: Baseline, 3 months, and 6 months postoperatively.
Change in gingival recession depth measured in millimeters (mm) from the cementoenamel junction to the free gingival margin using a UNC-15 periodontal probe. Lower values indicate better root coverage outcomes.
Baseline, 3 months, and 6 months postoperatively.
Width of Attached Gingiva
Periodo de tiempo: Baseline, 3 months, and 6 months postoperatively.
Change in the width of attached gingiva measured in millimeters (mm) using a UNC-15 periodontal probe. Higher values indicate improved gingival tissue augmentation and periodontal stability.
Baseline, 3 months, and 6 months postoperatively.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Periodontal Probing Depth
Periodo de tiempo: Baseline, 3 months, and 6 months postoperatively.
Change in periodontal probing depth measured in millimeters (mm) using a UNC-15 periodontal probe at treated sites. Lower values indicate better periodontal health.
Baseline, 3 months, and 6 months postoperatively.
Relative Clinical Attachment Level
Periodo de tiempo: Baseline, 3 months, and 6 months postoperatively.
Change in relative clinical attachment level measured in millimeters (mm) using a UNC-15 periodontal probe. Lower values indicate improved periodontal attachment.
Baseline, 3 months, and 6 months postoperatively.
Early Wound Healing Index
Periodo de tiempo: 1 week, 2 weeks, and 4 weeks postoperatively.

Early wound healing assessed clinically using the Early Healing Index (EHI). The scale ranges from 1 to 5, where:

1 = Complete flap closure without fibrin line (best healing) 5 = Incomplete flap closure with complete tissue necrosis (worst healing)

Lower scores indicate better healing outcomes.

1 week, 2 weeks, and 4 weeks postoperatively.
Patient Satisfaction
Periodo de tiempo: 3 months and 6 months postoperatively.

Patient satisfaction assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where:

0 = Completely dissatisfied 10 = Completely satisfied

Higher scores indicate greater patient satisfaction with the treatment outcome.

3 months and 6 months postoperatively.
Postoperative Pain
Periodo de tiempo: 1 week and 2 weeks postoperatively.

Postoperative pain assessed using a Visual Analog Scale (VAS). The scale ranges from 0 to 10, where:

0 = No pain 10 = Worst imaginable pain

Lower scores indicate less postoperative pain and discomfort.

1 week and 2 weeks postoperatively.

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Director de estudio: Saleh Al Kurdi, PhD, Arab International University
  • Investigador principal: Rania Daadoush, DDs, Damascus University
  • Silla de estudio: Tarek Qasem, PhD, Damascus University

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.

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)

12 de agosto de 2025

Finalización primaria (Actual)

12 de enero de 2026

Finalización del estudio (Actual)

25 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

9 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

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

9 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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