NCT Number: NCT07803757
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.
Trial opening soon.
Get Notified35 year–55 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Tooth-related criteria:
Exclusion criteria
Tooth-related criteria:
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.
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.
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).
Other names: Riva Light Cure, HVGIC
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Other names: Riva Self Cure, RMGIC
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: perioperatively
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Rawda Abd ElAziz Hesham Abd ElAziz
CONTACT
marwa ashraf husseiny, Master's candidate
CONTACT
Cairo University
Other
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
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