Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.

30 de agosto de 2026 actualizado por: Mai Magdy Abu El Eneen, Cairo University

The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial

The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.

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

Ubicaciones de estudio

  • Egipto
      • Cairo, Egipto, 11562
        • Faculty of dentistry cairo ubiversity
        • Contacto:

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

No

Descripción

Inclusion Criteria:

  • • Age ≥ 18 years.

    • Systemically healthy.
    • Non-smokers.
    • Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
    • Presence of identifiable CEJ.
    • Absence of non-carious cervical lesions.
    • Mature permanent tooth in the aesthetic zone.
    • At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
    • Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
    • A minimum of (2 mm KTW).

Exclusion Criteria:

  • Any systemic disease.
  • Pregnancy or lactation.
  • Cairo RT3 recession defects.
  • Teeth with active orthodontic treatment.
  • Previous periodontal surgery in the area.
  • Use of any drugs that might lead to gingival enlargement.
  • Smoking.
  • Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Procedimiento: Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
Experimental: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
Procedimiento: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in recession depth (mm)
Periodo de tiempo: at Baseline and 6 months
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
at Baseline and 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gingival Recession Width (mm)
Periodo de tiempo: at baseline and 6 months
Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction.
at baseline and 6 months
Keratinized Tissue Width (mm)
Periodo de tiempo: at Baseline and 6 months
Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique
at Baseline and 6 months
Keratinized Tissue Height (mm)
Periodo de tiempo: at Baseline and 6 months
Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
at Baseline and 6 months
Probing Depth (mm)
Periodo de tiempo: at Baseline and 6 months
Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva.
at Baseline and 6 months
Gingival Thickness (mm)
Periodo de tiempo: at Baseline and 6 months
Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm.
at Baseline and 6 months
Recession Reduction (mm)
Periodo de tiempo: at Baseline and 6 months
Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe.
at Baseline and 6 months
Clinical Attachment Level (mm)
Periodo de tiempo: at Baseline and 6 months
Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus.
at Baseline and 6 months
Complete Root Coverage (%)
Periodo de tiempo: at 6 months
Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group.
at 6 months
Bleeding on Probing (+/-)
Periodo de tiempo: at Baseline and 6 months
Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal. A positive finding for BOP will be recorded when bleeding occurred within 10s.
at Baseline and 6 months
Plaque Index (scores 0, 1, 2, 3)
Periodo de tiempo: at Baseline and 6 months

Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth.

Scores:

0 : No plaque

1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye.

3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
at Baseline and 6 months
Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
Periodo de tiempo: Surgical day and days 1, 3, 7, and 14 after surgery
Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen). A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain.
Surgical day and days 1, 3, 7, and 14 after surgery
Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
Periodo de tiempo: at 6 months
Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit. The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration). A total RES score will be calculated by adding these 5 components
at 6 months
Mean Percentage of Root Coverage (mRC) %
Periodo de tiempo: (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = [(RD₀ - RD6) / RD₀] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment.
(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100

Colaboradores e Investigadores

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

Patrocinador

Cairo University

Investigadores

  • Investigador principal: Mai Magdy Abu El Eneen, PHD candidate, Cairo University

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 (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2026

Publicado por primera vez (Actual)

3 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

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

30 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • preliminary decision

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

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. .

Suscribir