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Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Sponsor: Cairo University
Summary
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 two parallel arms and a 1:1 allocation ratio. SMART arms will receive 38% silver diamine fluoride (SDF) and potassium iodide followed by high-viscosity glass ionomer cement (HVGIC) ), while the conventional arms will receive standard tooth preparation followed by HVGIC 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, 9and 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.
Official title: Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial(
Key Details
Gender
All
Age Range
45 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2027-01-15
Completion Date
2028-01-15
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Silver Diamine Fluoride (SDF, 38%)
38% Silver Diamine Fluoride applied to the carious lesion using a micro brush for one minute, followed by application of potassium iodide (KI)Applied in the SMART group 1-3 times until the precipitate clears to reduce black staining, prior to restoration. Used in SMART arm only, with no mechanical removal of carious dentin.
Conventional Tooth Preparation
Conventional mechanical excavation of carious dentin using sharp hand instruments and air-turbine handpiece, burs and excavators; selective caries removal , followed by cavity conditioning with 10% polyacrylic acid, rinsing, and drying, prior to restoration. No SDF is applied in this procedure.
High-Viscosity Glass Ionomer Cement
High-viscosity glass ionomer restorative cement placed and cured according to tooth location, following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).