Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Adult cancer patients (35‐55 years) with primary cervical carious lesions will berecruited from the outpatient clinics of the Faculty of Dentistry, Cairo University.Eligible teeth must be vital by pulp sensitivity testing with controlled periodontalconditions; 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 acomputer‐generated sequence (random.org) with allocation concealed via sequentiallynumbered, opaque, sealed envelopes. The study is double‐blinded (participants and outcomeassessors blinded; the treating operator is not blinded). Baseline data collectionincludes medical/dental history and pre‐operative radiographs. Interventions will beapplied by a single trained operator following standardized protocols for SDF/GICplacement (SMART arms) or conventional cavity preparation and GIC placement (controlarms). 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‐measuresANOVA/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 retentiondata. The trial is self‐funded, with independent auditing conducted by the co‐supervisor.
Epistemonikos ID: cdd8ee98396644a37ab1bc632b79b4a048f91815
First added on: Sep 05, 2026