Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients
2 de septiembre de 2026 actualizado por: Marwa Ashraf Husseiny, Cairo University
Clinical Performance of Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment for Elderly Cancer Patients: A 12-Month Randomized Clinical Trial
This study will evaluate the clinical performance of glass ionomer cervical restorations placed using the Silver-Modified Atraumatic Restorative Technique (SMART) compared with conventional restorative treatment in elderly cancer patients with cervical carious lesions.
The trial is a 12-month randomized clinical trial with four parallel arms and a 1:1 allocation ratio.
Two SMART arms will receive 38% silver diamine fluoride (SDF) and potassium iodide followed by either high-viscosity glass ionomer cement (HVGIC) or resin-modified glass ionomer cement (RMGIC), while the conventional arms will receive standard tooth preparation followed by HVGIC or RMGIC without SDF.
The primary outcome is retention of the restoration, assessed using USPHS criteria.
Secondary outcomes include postoperative hypersensitivity, marginal integrity, recurrent caries, average duration of treatment, anatomic form, color match, surface roughness, marginal discoloration, and patient satisfaction (VAS).
Patients will be followed at baseline, 3, 6, and 12 months.
The study aims to determine whether the minimally invasive SMART approach offers comparable clinical performance to conventional treatment while reducing chair time and discomfort in a medically vulnerable elderly cancer population.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Adult cancer patients (35-55 years) with primary cervical carious lesions will be recruited from the outpatient clinics of the Faculty of Dentistry, Cairo University.
Eligible teeth must be vital by pulp sensitivity testing with controlled periodontal conditions; teeth with previous restorations, irreversible pulpitis signs, mobility, resorption, or cuspal loss will be excluded, as will patients with material allergies, fixed orthodontic appliances, pregnancy, or frequent analgesic use that could mask pain.
After signing informed consent, participants will be randomized 1:1 using a computer-generated sequence (random.org)
with allocation concealed via sequentially numbered, opaque, sealed envelopes.
The study is double-blinded (participants and outcome assessors blinded; the treating operator is not blinded).
Baseline data collection includes medical/dental history and pre-operative radiographs.
Interventions will be applied by a single trained operator following standardized protocols for SDF/GIC placement (SMART arms) or conventional cavity preparation and GIC placement (control arms).
Data will be collected on paper/Excel and analyzed using MedCalc software (v22) with Chi-square, Cochran's Q, one-way ANOVA/Tukey post-hoc, and repeated-measures ANOVA/Bonferroni-corrected comparisons, with significance set at p≤0.05 and 80% power.
Sample size (29 teeth/group) was calculated using G*Power based on prior HVGIC retention data.
The trial is self-funded, with independent auditing conducted by the co-supervisor.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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: marwa ashraf husseiny, Master's candidate
- Número de teléfono: +201061388709
- Correo electrónico: marwa.husseiny@dentistry.cu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Rawda Abd ElAziz Hesham Abd ElAziz
- Correo electrónico: rawda.hesham@dentistry.cu.edu.eg
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:
- Patient-related criteria:
- Adult cancer patients of both genders, aged 35-55 years
- Good oral hygiene
- Willing to sign the informed consent
- Co-operative patients who accept the follow-up period
Tooth-related criteria:
- Teeth with primary root surface caries (active dentin carious lesions, Nyvad score 2 or 3)
- Teeth with gum recession
- Teeth vital according to pulp sensitivity tests
- Controlled gingival or periodontal conditions
Exclusion Criteria:
- Patient-related criteria:
- Allergy to any of the restorative materials
- Patients undergoing orthodontic treatment with fixed appliances
- Pregnant women
- Patients who frequently use analgesics or any drugs that could mask pain
Tooth-related criteria:
- Teeth with previous restorations
- Spontaneous or prolonged pain (more than 15 seconds) after cold test, indicating irreversible pulpitis
- Negative sensibility test, periapical radiolucency, or sensitivity to percussion
- Mobile teeth indicating periodontal disease or trauma
- External or internal resorption
- Chipped teeth or cuspal loss
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 |
|---|---|
|
Experimental: SMART with High-Viscosity GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
|
38% Silver Diamine Fluoride applied to the carious lesion using a micro brush for one minute, followed by application of potassium iodide (KI) in esthetically sensitive areas to reduce black staining, prior to restoration.
Used in the two SMART arms only, with no mechanical removal of carious dentin.
High-viscosity glass ionomer restorative cement placed and light-cured according to tooth location, following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Otros nombres:
|
|
Experimental: SMART with Resin-Modified GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
|
38% Silver Diamine Fluoride applied to the carious lesion using a micro brush for one minute, followed by application of potassium iodide (KI) in esthetically sensitive areas to reduce black staining, prior to restoration.
Used in the two SMART arms only, with no mechanical removal of carious dentin.
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Otros nombres:
|
|
Experimental: Conventional with Resin-Modified GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), without prior SDF application.
|
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Otros nombres:
Conventional mechanical excavation of carious dentin using sharp hand instruments and round steel burs in a slow-speed handpiece, followed by cavity conditioning with 10% polyacrylic acid, rinsing, and drying, prior to restoration.
No SDF is applied in this procedure.
|
|
Comparador activo: Conventional with High-Viscosity GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, without prior SDF application.
|
High-viscosity glass ionomer restorative cement placed and light-cured according to tooth location, following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Otros nombres:
Conventional mechanical excavation of carious dentin using sharp hand instruments and round steel burs in a slow-speed handpiece, followed by cavity conditioning with 10% polyacrylic acid, rinsing, and drying, prior to restoration.
No SDF is applied in this procedure.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retention of Restoration
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Evaluation of the presence and integrity of the restoration over the follow-up period, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - restoration present; Bravo (B) - partial loss, clinically acceptable; Charlie (C) - clinically unacceptable partial/total loss; Delta (D) - immediate replacement necessary.
|
Baseline, 3 months, 6 months, and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Hypersensitivity
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Assessment of patient-reported sensitivity following restoration placement, evaluated using USPHS criteria (Zhao et al., 2018): Alpha (A) - no hypersensitivity; Bravo (B) - mild hypersensitivity; Charlie (C) - moderate hypersensitivity; Delta (D) - severe hypersensitivity.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Marginal Integrity
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Description: Evaluation of the continuity and adaptation at the restoration margins, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - continuity at the margin; Bravo (B) - slight discontinuity at the margin; Charlie (C) - marginal defects requiring replacement.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Recurrent Caries
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Detection of caries adjacent to restoration margins, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - caries absent; Charlie (C) - caries present.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Average Duration of Treatment
Periodo de tiempo: perioperatively
|
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
|
perioperatively
|
|
Anatomic Form
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Assessment of whether the restoration correctly mimics the natural contours, height, and functional shape of the original tooth, using USPHS criteria (Zhao et al., 2018): Alpha - restoration continuous with existing anatomic form; Bravo - continuous but not exposing cement or dentin; Charlie - sufficient material lost to expose cement material or dentin.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Color Match
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Measures how well the shade of the restorative material blends with the neighboring natural tooth structure, using USPHS criteria (Zhao et al., 2018): Alpha - no mismatch; Bravo - mismatch within normal range of color, shade, and translucency; Charlie - mismatch outside normal range.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Surface Roughness and Marginal Discoloration
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
|
Combined assessment of restoration surface smoothness and marginal staining using USPHS criteria (Zhao et al., 2018): Surface roughness scored Alpha (smooth) to Charlie (rough, cannot be refinished); marginal discoloration scored Alpha (none) to Charlie (discoloration penetrated in pulpal direction).
|
Baseline, 3 months, 6 months, and 12 months
|
|
Patient Satisfaction
Periodo de tiempo: Immediately after the intervention, and at 3, 6, and 12 months
|
Patient-reported satisfaction with treatment, measured using a Visual Analog Scale (VAS) from 0 (unsatisfied) to 10 (totally satisfied), where the patient marks a vertical line across the scale and the distance in millimeters from the zero end is measured (Golpak, 2020).
|
Immediately after the intervention, and at 3, 6, and 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
15 de enero de 2027
Finalización primaria (Estimado)
15 de julio de 2027
Finalización del estudio (Estimado)
15 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Publicado por primera vez (Actual)
4 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- cons sdf 4-2-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The dataset contains coded but potentially re-identifiable clinical and patient information.
Per the study's confidentiality plan, data access is restricted to the principal investigator and study supervisors only, with records stored securely under password-protected, limited-access systems.
No plan for sharing individual participant data with external researchers is currently in place.
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
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