Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Carious Cervical Lesions
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 21 años - 45 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 50 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
Leer la descripción completa
Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.
For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Patient-related Criteria:
A) Inclusion Criteria:
- Patients consulting in the outpatient clinic with cervical carious lesion.
- Age between 21-45 years.
- Males and females.
B) Exclusion Criteria:
- Systemic disease or severe medical complication.
- Allergy to any of the restorative materials.
- Pregnancy.
- Disabilities.
- Heavy smoking; xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
Tooth-related Criteria:
A) Inclusion Criteria:
- Small to moderate class V carious lesion.
- Teeth are vital with no signs of irreversible pulpitis.
- Caries cervical margins above the CEJ.
- Well-formed and fully erupted in normal functional occlusion with natural antagonist.
B) Exclusion Criteria:
- Deciduous teeth; as the study is targeting only permanent teeth.
- Deep carious defects (close to the pulp, less than 1 mm distance).
- Tooth hypersensitivity.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Heavy occlusion and occlusal contacts or history of bruxism.
- Endodontically treated teeth.
- Periapical pathology or signs of pulpal pathology.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia)
No informado en este registro.
Procedure: Class V Restoration - Stela
Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany)
No informado en este registro.
Procedure: Class V Restoration - Polofil
Class V Restoration - Polofil PROCEDURE
A class V cavity with 1 mm occlusal bevel will be prepared after administering local anesthesia. Rubber dam isolation will be done, , etching of the enamel (20-30 seconds) and dentin (15 seconds) using a 35% phosphoric acid etch (Kulzer Gluma Etch, Kulzer GmbH, Germany), then rinsing for 20 seconds followed by controlled drying of the cavity till it's slightly moist. Application of the bonding agent (Solobond M, Voco GmbH, Germany) using a disposable brush and leaving it to act for 30 seconds then an air jet will be used to disperse the bonding agent. Curing for 20 seconds will be done using a LED light curing unit with curing intensity 1200-3000 mw/cm2 (CuringPen-E, Changzhou Sifary Medical Technology Co., Ltd, China). Flowable composite (Polofil NHT flow, Voco GmbH, Germany) will be placed, adapted by gold plated applicator then light polymerized for 20 seconds using light emitting diode (LED) light curing unit.
Class V Restoration - Stela PROCEDURE
A class V cavity with 1 mm occlusal bevel will be prepared after administrating local anesthesia followed by rubber dam isolation. Stela Primer (SDI Limited, Australia.) will be applied for 5 seconds on the cavity and the margins, then it will be gently dried with air for 2-3 seconds without light curing. The self-cure bulk fill resin composite (Stela Automix or Stela Capsule, SDI Limited, Australia) will be applied then sculpted using a gold-plated composite applicator (Lascod, Italy). Full polymerization will take place after 4 minutes.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Retention
Plazo: 18 Months
The restoration will be clinically assessed according to the modified USPHS criteria. Restoration will be given Alpha score when there is no loss of restoration. It will be given a Charlie score when there is loss of restoration and need for replacement.
Medidas secundarias
Marginal Adaptation
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when the restoration is closely adapted with no detectable margin. It will be given a Bravo score when there is a detectable marginal discrepancy, but it still clinically acceptable. It will be given a Charlie score when there is a marginal crevice that is clinically unacceptable.
Marginal Discoloration
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no discoloration between the tooth and the restoration. It will be given a Bravo score when there is superficial discoloration which can be polished away. It will be give a Charlie score when the discoloration has penetrated beyond the margin in pulpal direction.
Post-operative Sensitivity
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when there is no post-operative sensitivity and a Charlie score when there is post-operative sensitivity.
Recurrent Caries
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no detectable recurrent caries and a Charlie score when recurrent caries is detected.
Surface Roughness
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no surface defect. It will be given a bravo score when there is minimal surface defect. It will be given a charlie score when there is a severe surface defect.
Color Match
Plazo: 18 months
The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when the restoration matches the color of the tooth. It will be give a Bravo score when there is an acceptable mismatch. It will be given a Charlie score when there is an unacceptable mismatch.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Faculty of Dentistry, Cairo UniversityCairo, EgyptEstado desconocido
Equipo y fechas
- Patrocinador principal
- Cairo University
- Inicio del estudio
- 2026-12 Estimado
- Finalización primaria
- 2027-02 Estimado
- Finalización del estudio
- 2027-04 Estimado
- Primera publicación
- 8 may 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026