- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07614451
This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.
A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
First Validation of endodontic treatment using a periapical radiograph and proper history taking.
{I}• Cavity Preparation Procedures for Comparator Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- Removal of all undermined enamel.
- Then 1.5 to 2 mm cusp reduction will be performed for the buccal and lingual walls.
- The occlusal box will be of 2.5 mm width, 2 mm depth cavity walls and will be flared to produce a 6 degree of divergence.
- The cavity will have internal rounded angles, finished enamel with sharp non-beveled margins and smooth well-defined walls.
- Immediate Dentin Sealing and Cavity Optimization: Immediate dentin sealing will be performed through the use of a universal adhesive followed by the injection of injectable flowable resin composite. Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The final retentive design will include occlusal clearance of 2 mm with occlusal box cavity of depth 2 mm with all margins in enamel occlusally and all dentin surfaces will be covered.
{II}• Cavity Preparation Procedures for Intervention Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- No additional removal of the tooth structure will be performed at this step.
- Cavity optimization will be performed first.
- Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The occlusal cavity will be restored during cavity optimization with injectable resin composite to reduce the areas of dentin exposure and preserve the remaining tooth structure.
- The dentin substitute resin composite will establish the biobase.
- An anatomical non retentive preparation design will be performed to show continuous inclined plane preparation with 2 mm cuspal reduction, concave chamfer margins, and 1 to 1.5 mm thick butt-joint preparation in the interproximal portion.
The final cavity design will include occlusal clearance of 2 mm with total cusp coverage, with biomimetic features (anatomical, non-retentive design) with no occlusal box cavity.
- The CAD/CAM partial coverage overlay restoration will be designed, then milled using SHOFU Hard hybrid ceramic blocks for both groups following its design.
- Cementation for both groups:
- Selective etching of the enamel margins of the cavity will be made using 37% phosphoric acid.
- Application of Universal Adhesive according to manufacturer's instructions and cured.
- Regarding the milled indirect overlay restorations; surface roughening with Dura-Green Stones SHOFU will be performed, followed by the application of a suitable priming agent, then the injection of resin cement in the fitting surface, and finally the restoration will be cemented.
- Restoration will be placed onto the prepared cavities allowing for excess resin cement to emerge which will then be tac-cured for 5 second using a standard intensity light cure allowing for slight hardening of the excess resin cement.
- Removal of excess cement using a sharp explorer, excavator or a c-blade along with the use of interdental flossing to ensure elimination of interdental excess resin cement material.
- Completing the remaining curing cycle after excess removal to the full curing time.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sara Ibrahim Fahmy, PhD
- Número de teléfono: 002 01006256086
- Correo electrónico: sara.fahmy@dentistry.cu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Aya Mohamed Adly, Lecturer
- Correo electrónico: aya.mohamed@dentistry.cu.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patient Related Criteria:
- Adult patients (age: 20-60 years) of both genders.
- Healthy patients (not suffering of any systematic or chronic diseases).
- Able to tolerate the necessary restorative procedures.
- Willing to sign the informed ethical consent.
- Accepts the follow-up period.
Tooth Related Criteria:
- Proper endodontically treated teeth.
- First and second permanent molars.
- Absence of any peri-apical lesions.
- Absence of any periodontal disease involvement.
- Large access cavities with one or two missing walls.
- Patients with proper oral hygiene.
- Presence of opposing tooth.
Exclusion Criteria:
- Patient related:
- Patients younger than 20 or older than 60 years old.
- Pregnant females.
- Patients with any systemic or chronic diseases.
- Patients not accepting the follow-up period.
- Patients not willing to sign the informed ethical consent.
- Patients with known allergies to latex and/or resinous material.
Tooth related
- Endodontically treated anterior, premolar and third molar teeth.
- Hopelessly carious/destructed teeth necessitating extraction.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
- Poor endodontic treatment.
- Periapical lesion present.
- Cervical carious lesions involved.
Plan de estudios
¿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 |
|---|---|
|
Experimental: conventional retentive overlay design
|
Endodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design.
|
|
Experimental: minimal invasive non-retentive overlay design
|
Endodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Marginal adaptation (success rate)
Periodo de tiempo: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores) |
T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
proximal contact point 3.fracture of material and retention 4.wear 5. marginal staining 6. color match 7.caries at restoration margin
Periodo de tiempo: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores) |
T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Olfat ElSayed Hassanein, Professor, Conservative Dentistry, Faculty of Dentistry, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 12041994
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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