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

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.

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.

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