Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
28 de julio de 2026 actualizado por: Medical University of Warsaw
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
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: Małgorzata Wyszyńska-Pomian
- Número de teléfono: +48 504006984
- Correo electrónico: malgorzata.wyszynska@wum.edu.pl
Copia de seguridad de contactos de estudio
- Nombre: Bartłomiej Górski
- Número de teléfono: +48221166431
- Correo electrónico: bartlomiej.gorski@wum.edu.pl
Ubicaciones de estudio
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Bialystok, Polonia, 15276
- Department of Integrated Dentistry, University of Białystok
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Contacto:
- Anna Skurska
- Correo electrónico: annaskurska@wp.pl
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Szczecin, Polonia
- Department of Periodontology, Pomeranian Medical University Contact
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Contacto:
- Monika Machoy
- Correo electrónico: monika.machoy@pum.edu.pl
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Warsaw
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Warsaw, Warsaw, Polonia, 00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
Exclusion Criteria:
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
- Pregnant and lactating females
- Previous periodontal surgery in the examined area
- III-degree mobility
- Furcation involvement
- Pulpal pathology or inadequate endodontic 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 |
|---|---|
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Comparador activo: Entire Papilla Preservation Technique (EPPT) + EMD
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed.
Flaps are repositioned and sutured for primary closure.
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A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
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Experimental: Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material.
A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.
|
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical Attachment Level gain (CAL, mm)
Periodo de tiempo: 6 months and 12 months
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Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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6 months and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Probing Pocket Depth (PPD, mm)
Periodo de tiempo: Baseline, 6 months and 12 months
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Probing Pocket Depth (PPD), measured in millimeters (mm), defined as the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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Baseline, 6 months and 12 months
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Probing Pocket Depth reduction (PPD, mm)
Periodo de tiempo: 6 months and 12 months
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Probing Pocket Depth (PPD) reduction, measured in millimeters (mm), defined as the change from baseline in the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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6 months and 12 months
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Clinical Attachment Level (CAL, mm)
Periodo de tiempo: Baseline, 6 months, and 12 months
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Clinical Attachment Level (CAL), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
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Baseline, 6 months, and 12 months
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Gingival Recession (GR, mm)
Periodo de tiempo: Baseline, 6 months and 12 months
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Gingival recession (GR), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the gingival margin, assessed using a calibrated periodontal probe.
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Baseline, 6 months and 12 months
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Keratinized Tissue Width (KTW, mm)
Periodo de tiempo: Baseline, 6 months and 12 months
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Keratinized tissue width (KTW), measured in millimeters (mm), defined as the distance from the gingival margin to the mucogingival junction, assessed using a periodontal probe.
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Baseline, 6 months and 12 months
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Gingival Thickness (GT, mm)
Periodo de tiempo: Baseline, 6 months and 12 months
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Gingival thickness (GT), measured in millimeters (mm) at the buccal aspect 3 mm apical to the gingival margin using a standardized transgingival probing method with an endodontic file and stopper.
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Baseline, 6 months and 12 months
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Soft Tissue Volumetric Change (mm³)
Periodo de tiempo: 6 months and 12 months
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Change from baseline in soft tissue volume, expressed in cubic millimeters (mm³), assessed by superimposition of digital intraoral scans (STL files) using dedicated software with standardized reference areas.
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6 months and 12 months
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Radiographic Linear Defect Fill (LDF, mm)
Periodo de tiempo: 6 months and 12 months
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Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
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6 months and 12 months
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Radiographic Percentage Defect Fill (%DF)
Periodo de tiempo: 6 months and 12 months
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Percentage defect fill (%DF), expressed as a percentage (%), calculated based on standardized measurements obtained from periapical radiographs using a reproducible measurement protocol to assess bone defect resolution.
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6 months and 12 months
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Early Wound Healing Score (EHS)
Periodo de tiempo: 1 week and 2 weeks
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Early wound healing will be assessed using the Early Wound Healing Score (EHS), a composite clinical index ranging from 0 to 10 based on re-epithelialization, hemostasis, and inflammation, with higher scores indicating better healing.
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1 week and 2 weeks
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Full-Mouth Plaque Score (FMPS, %)
Periodo de tiempo: Baseline, 6 months, and 12 months
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Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
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Baseline, 6 months, and 12 months
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Full-Mouth Bleeding Score (FMBS, %)
Periodo de tiempo: Baseline, 6 months, and 12 months
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Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
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Baseline, 6 months, and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Bartłomiej Górski, Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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 agosto de 2026
Finalización primaria (Estimado)
30 de septiembre de 2027
Finalización del estudio (Estimado)
30 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
2 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
30 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Perio.06
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
producto fabricado y exportado desde los EE. UU.
No
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