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)

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Enrollment reduced 25% 40 → 30 participants
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Record History

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  1. Minor Enrollment reduced: 40 → 30 participants Show 6 more changesShow less
    • Interventions modified
    • Trial arms changed: 4 → 2
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study title expanded, about 15 words
    • Study description shortened, about 1 word
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07803757
Lead Sponsor Cairo University
Conditions
(from sponsor)
Dental Caries, Cervical Caries
Related terms Dental Caries, Root Caries
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov